FDA Product Code
FDA Product Code FSP — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4800
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K895248 | IMS5000 ILLUMINATED LOUPES | Luxtec Corp. | 1989-09-15 | Traditional | PDF ↗ |
| K891895 | SURGICAL LOUPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | Traditional | PDF ↗ |
| K864386 | LUXTEC LOUPES FOR SURGICAL VISION | Luxtec Corp. | 1986-11-17 | Traditional | PDF ↗ |
| K861749 | 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE | Keeler Instruments, Inc. | 1986-05-23 | Traditional | PDF ↗ |
Product code FSP · Class I · General, Plastic Surgery. Data: openFDA.