510(k) K830456

STAPLE INSERTER-EXTRACTOR FOR ARTHROS by Instrument Makar, Inc. — Product Code HXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1983
Date Received
February 9, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple Driver
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type