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 |