The following data is part of a premarket notification filed by Friatec Medical Inc., Usa with the FDA for Surgical Instruments, Forceps & Graspers, Probes & Curettes.
| Device ID | K934332 |
| 510k Number | K934332 |
| Device Name: | SURGICAL INSTRUMENTS, FORCEPS & GRASPERS, PROBES & CURETTES |
| Classification | Arthroscope |
| Applicant | FRIATEC MEDICAL INC., USA 9229 CRANFORD DR. Potomac, MD 20854 |
| Contact | R.j. Slomoff |
| Correspondent | R.j. Slomoff FRIATEC MEDICAL INC., USA 9229 CRANFORD DR. Potomac, MD 20854 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-07 |
| Decision Date | 1994-03-25 |