The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Arthroscope Accessories.
Device ID | K944210 |
510k Number | K944210 |
Device Name: | ARTHROSCOPE ACCESSORIES |
Classification | Arthroscope |
Applicant | Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
Contact | Kenneth M Isser |
Correspondent | Kenneth M Isser 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 | 1994-08-29 |
Decision Date | 1995-02-14 |