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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tourniquet, Nonpneumatic
510(k) Number K881398
Device Name TOURNIQUET
Applicant
Barretta Products, Research and Development, Inc.
130 Durhu Dr., Dept. D
Mobile,  AL  36608
Applicant Contact CARL BARRETT
Correspondent
Barretta Products, Research and Development, Inc.
130 Durhu Dr., Dept. D
Mobile,  AL  36608
Correspondent Contact CARL BARRETT
Regulation Number878.5900
Classification Product Code
GAX  
Date Received04/04/1988
Decision Date 04/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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