510(k) K851482

TOURNIQUET by Polymer Technology Corp. — Product Code GAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1985
Date Received
April 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tourniquet, Nonpneumatic
Device Class
Class I
Regulation Number
878.5900
Review Panel
SU
Submission Type