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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tourniquet, Pneumatic
510(k) Number K910449
Device Name PRESTITCH
Applicant
Crantec Co.
120 Sports Mall Plz. 5505
South 900 E.
Salt Lake City,  UT  84117
Applicant Contact RICHARD CRANGLE
Correspondent
Crantec Co.
120 Sports Mall Plz. 5505
South 900 E.
Salt Lake City,  UT  84117
Correspondent Contact RICHARD CRANGLE
Regulation Number878.5910
Classification Product Code
KCY  
Date Received01/29/1991
Decision Date 05/29/1992
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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