510(k) K971315

AUXILIARY INSTRUMENTS FOR URS by Richard Wolf Medical Instruments Corp. — Product Code FCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1997
Date Received
April 9, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Non-Electric
Device Class
Class I
Regulation Number
876.1075
Review Panel
GU
Submission Type