The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Se5 Arthroscopy Sytem.
| Device ID | K941333 |
| 510k Number | K941333 |
| Device Name: | SE5 ARTHROSCOPY SYTEM |
| Classification | Arthroscope |
| Applicant | Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Contact | Roy S Chin |
| Correspondent | Roy S Chin Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-18 |
| Decision Date | 1994-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327060591 | K941333 | 000 |