The following data is part of a premarket notification filed by Henke-sass Wolf, Gmbh. with the FDA for Hsw Laparoscope And Accessories.
| Device ID | K941967 |
| 510k Number | K941967 |
| Device Name: | HSW LAPAROSCOPE AND ACCESSORIES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | HENKE-SASS WOLF, GMBH. KRONENSTRASSE 16 Tuttlingen, DE 78532 |
| Contact | A. Lekitsch |
| Correspondent | A. Lekitsch HENKE-SASS WOLF, GMBH. KRONENSTRASSE 16 Tuttlingen, DE 78532 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-22 |
| Decision Date | 1994-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556611142 | K941967 | 000 |
| 00885556572924 | K941967 | 000 |
| 00885556572917 | K941967 | 000 |
| 00885556572900 | K941967 | 000 |
| 00885556572894 | K941967 | 000 |
| 03596010618726 | K941967 | 000 |
| 03596010618719 | K941967 | 000 |
| 03596010618702 | K941967 | 000 |