510(k) K781766

UTERINE SOUND, BURNETT DISPOSABLE by C.R. Bard, Inc. — Product Code HHM

K781766 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "UTERINE SOUND, BURNETT DISPOSABLE". The FDA issued a decision of Substantially Equivalent on December 7, 1978. The device falls under product code HHM (Sound, Uterine), a Class I device regulated under 21 CFR 884.4530. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1978
Date Received
October 16, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sound, Uterine
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type