The following data is part of a premarket notification filed by Chirurgische Instrumente with the FDA for Cit Biopsy Punches.
Device ID | K944444 |
510k Number | K944444 |
Device Name: | CIT BIOPSY PUNCHES |
Classification | Forceps, Biopsy, Gynecological |
Applicant | CHIRURGISCHE INSTRUMENTE HAUPTSTRABE 18 Balgheim, DE D-78582 |
Contact | Beate Schoppler |
Correspondent | Beate Schoppler CHIRURGISCHE INSTRUMENTE HAUPTSTRABE 18 Balgheim, DE D-78582 |
Product Code | HFB |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-12 |
Decision Date | 1995-09-29 |