510(k) K834170

OP-CON SURG. INSTRUMENT #10 by Imm Enterprises , Ltd. — Product Code GWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1984
Date Received
November 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor
Device Class
Class I
Regulation Number
882.1700
Review Panel
NE
Submission Type