510(k) K915763

MODIFIED DISPOSABLE FETAL VACUUM by Columbia Medical & Surgical, Inc. — Product Code HDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1992
Date Received
December 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractor, Vacuum, Fetal
Device Class
Class II
Regulation Number
884.4340
Review Panel
OB
Submission Type