510(k) K896960

INTRAUTERINE INSEMINATION CATHETERS by C.R. Bard, Inc. — Product Code HDR

K896960 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "INTRAUTERINE INSEMINATION CATHETERS". The FDA issued a decision of Substantially Equivalent on June 26, 1990. The device falls under product code HDR (Cap, Cervical), a Class II device regulated under 21 CFR 884.5250. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1990
Date Received
December 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Cervical
Device Class
Class II
Regulation Number
884.5250
Review Panel
OB
Submission Type