510(k) K820519

BIOPSER by Advanced Biomedical Instruments — Product Code HFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1982
Date Received
February 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Gynecological
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type