The following data is part of a premarket notification filed by Fetzer Medical Gmbh & Co. Kg with the FDA for Fetzer Medical Gynecological Forceps.
Device ID | K172661 |
510k Number | K172661 |
Device Name: | Fetzer Medical Gynecological Forceps |
Classification | Forceps, Surgical, Gynecological |
Applicant | Fetzer Medical GmbH & Co. KG Unter Buchsteig 5 Tuttlingen, DE 78532 |
Contact | Harald Jung |
Correspondent | Harald Jung Fetzer Medical GmbH & Co. KG Unter Buchsteig 5 Tuttlingen, DE 78532 |
Product Code | HCZ |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-05 |
Decision Date | 2018-05-08 |
Summary: | summary |