FDA Product Code
FDA Product Code FRP — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5680
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K082367 | INFANT SLEEP BEANIE | Life Innovations, LLC | 2009-06-12 | Traditional | PDF ↗ |
| K090284 | RES-Q INFANT WEDGE AND SLING | Cr Enterprises, LLC | 2009-06-05 | Traditional | PDF ↗ |
| K062143 | KOZY COMFORT INFANT POSITIONER | Alfred E Mann Inst. For Biomedical Engineering | 2006-10-24 | Traditional | PDF ↗ |
| K060986 | HEAD BED | Steven H. Warnock, M.D. | 2006-07-11 | Traditional | PDF ↗ |
| K051300 | ROBIN HOOD VEST | Kamber Corporation | 2005-12-08 | Traditional | PDF ↗ |
| K041996 | NIGHTFORM | Plastic Surgery Solutions, LLC | 2004-08-03 | Traditional | PDF ↗ |
| K003511 | KENDALL-LTP TURNER SAVE-A-LINE | The Ludlow Company LP | 2001-01-24 | Traditional | PDF ↗ |
| K943017 | NEONATAL RESTRAINT AND COMFORT SYSTEMS | K.Bowmed, Inc. | 1995-01-19 | Traditional | PDF ↗ |
| K932636 | THE TUCKER SLING | Tucker Designs, Ltd. | 1994-01-26 | Traditional | PDF ↗ |
| K905630 | INFANT REFLUX SLING | Pedicraft, Inc. | 1991-03-13 | Traditional | PDF ↗ |
| K905629 | PEDICRAFT INFANT REFLUX WEDGE | Pedicraft, Inc. | 1991-03-13 | Traditional | PDF ↗ |
| K882544 | CUDDLE UP PILLOW | Ohio Medical Instrument Co., Inc. | 1989-01-31 | Traditional | PDF ↗ |
| K844176 | PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS | Premie Comfort Products | 1985-01-23 | Traditional | PDF ↗ |
| K810609 | PEDIATRIC POSITION HOLDER | Kaye Products, Inc. | 1981-03-20 | Traditional | PDF ↗ |
Product code FRP · Class I · General Hospital. Data: openFDA.