FQP — Lamp, Operating-Room Class II
FDA product code FQP covers "Lamp, Operating-Room", a Class II medical device regulated under 21 CFR 878.4580. Submissions are reviewed by the General, Plastic Surgery panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FQP
- Device Class
- Class II
- Regulation Number
- 878.4580
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K001223 | aculux | ACULUX, MODEL AX3001, AX3002 | June 23, 2000 |
| K993314 | synthes (usa) | SYNTHES LIGHT GUIDE | December 6, 1999 |
| K781581 | american sterilizer | SURGICAL LIGHT 22 SERIES | October 17, 1978 |
| K770812 | sybron | HANDLES, LIGHT, SURGICAL, STEOILE | May 23, 1977 |
| K761018 | amsco | SURGICAL LIGHT - CHALLENGE 22 SERIES | January 26, 1977 |