The following data is part of a premarket notification filed by Conceptus, Inc. with the FDA for Cervical Catheter.
Device ID | K933981 |
510k Number | K933981 |
Device Name: | CERVICAL CATHETER |
Classification | Cannula, Manipulator/injector, Uterine |
Applicant | CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
Contact | Alexis Ball |
Correspondent | Alexis Ball CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
Product Code | LKF |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-16 |
Decision Date | 1994-12-27 |