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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 K852277
Device Name CATAPRESS TOURNIGUET
Applicant
Boehringer Ingelheim Pharmaceuticals, Inc.
90 E. Ridge
P.O. Box 368
Ridgefield,  CT  06877
Applicant Contact RUTH WASSERMAN
Correspondent
Boehringer Ingelheim Pharmaceuticals, Inc.
90 E. Ridge
P.O. Box 368
Ridgefield,  CT  06877
Correspondent Contact RUTH WASSERMAN
Regulation Number878.5900
Classification Product Code
GAX  
Date Received05/29/1985
Decision Date 06/27/1985
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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