The following data is part of a premarket notification filed by Chirurgische Instrumente with the FDA for Cit Monopolar Laparoscopic Instrments.
| Device ID | K944270 |
| 510k Number | K944270 |
| Device Name: | CIT MONOPOLAR LAPAROSCOPIC INSTRMENTS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| 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 | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-01 |
| Decision Date | 1995-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250325437463 | K944270 | 000 |
| 04250325436473 | K944270 | 000 |
| 04250325436312 | K944270 | 000 |
| 04250325431430 | K944270 | 000 |
| 04250325429529 | K944270 | 000 |
| 04250325421004 | K944270 | 000 |
| 04250325419827 | K944270 | 000 |
| 04250325411692 | K944270 | 000 |