FDA Product Code
FDA Product Code FEX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5090
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K911104 | PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 | Hgm Medical Laser Systems, Inc. | 1991-06-11 | Traditional | PDF ↗ |
| K771725 | BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. | Xomed, Inc. | 1977-09-26 | Traditional | PDF ↗ |
Product code FEX · Class I · Gastroenterology, Urology. Data: openFDA.