The following data is part of a premarket notification filed by Chirurgische Instrumente with the FDA for Cit Two Way Suctin And Irrigation Tubes.
Device ID | K944268 |
510k Number | K944268 |
Device Name: | CIT TWO WAY SUCTIN AND IRRIGATION TUBES |
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 | 1995-01-26 |