The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Endoscopy System For Facial Plastic Surgery.
| Device ID | K935235 |
| 510k Number | K935235 |
| Device Name: | ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY |
| Classification | Endoscope, Rigid |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Ronald K Smith |
| Correspondent | Ronald K Smith SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | GCM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-01 |
| Decision Date | 1995-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925019935 | K935235 | 000 |