The following data is part of a premarket notification filed by Henke-sass Wolf, Gmbh. with the FDA for Hsw Gmbh Hysteroscopes & Accessories.
| Device ID | K952186 |
| 510k Number | K952186 |
| Device Name: | HSW GMBH HYSTEROSCOPES & ACCESSORIES |
| Classification | Hysteroscope (and Accessories) |
| Applicant | HENKE-SASS WOLF, GMBH. POSTFACH 2459 Tuttlingen, DE 78507 |
| Contact | Armin Lekitsch |
| Correspondent | Armin Lekitsch HENKE-SASS WOLF, GMBH. POSTFACH 2459 Tuttlingen, DE 78507 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-09 |
| Decision Date | 1996-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010129840 | K952186 | 000 |