The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Arthroscopic Manual Surgical Instruments.
Device ID | K935221 |
510k Number | K935221 |
Device Name: | STRYKER ARTHROSCOPIC MANUAL SURGICAL INSTRUMENTS |
Classification | Arthroscope |
Applicant | Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
Contact | Tom Kelly |
Correspondent | Tom Kelly 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 | 1993-11-01 |
Decision Date | 1994-04-28 |