The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Operating Laparoscope.
| Device ID | K943100 |
| 510k Number | K943100 |
| Device Name: | STRYKER OPERATING LAPAROSCOPE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Contact | Larry Voss |
| Correspondent | Larry Voss Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-29 |
| Decision Date | 1995-08-10 |