The following data is part of a premarket notification filed by Conceptus, Inc. with the FDA for Intrauterine Catheter And Introducer.
Device ID | K932993 |
510k Number | K932993 |
Device Name: | INTRAUTERINE CATHETER AND INTRODUCER |
Classification | Cannula, Intrauterine Insemination |
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 | MFD |
CFR Regulation Number | 884.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-18 |
Decision Date | 1995-01-06 |