510(k) K863610

THE OB-GYN CONCEPTS VAGINAL ASPIRATOR by Ob/Gyn Concepts, Ltd. — Product Code KOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1987
Date Received
September 16, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, General Obstetric-Gynecologic
Device Class
Class I
Regulation Number
884.4520
Review Panel
OB
Submission Type