The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Intrauterine Insemination Catheters.
Device ID | K896960 |
510k Number | K896960 |
Device Name: | INTRAUTERINE INSEMINATION CATHETERS |
Classification | Cap, Cervical |
Applicant | C.R. BARD, INC. 5 FEDERAL ST. P.O. BOX 5069 Billerica, MA 01822 |
Contact | Ernest Manfredo |
Correspondent | Ernest Manfredo C.R. BARD, INC. 5 FEDERAL ST. P.O. BOX 5069 Billerica, MA 01822 |
Product Code | HDR |
CFR Regulation Number | 884.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-14 |
Decision Date | 1990-06-26 |