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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 K853472
Device Name FINGER TOURNIQUETTE
Applicant
JOSEPH B. MAROGIL
TOWERS MEDICAL BLDG. 515
21 MICHIGAN STREET NE
GRAND RAPIDS,  MI  49503
Applicant Contact JOSEPH B MAROGIL
Correspondent
JOSEPH B. MAROGIL
TOWERS MEDICAL BLDG. 515
21 MICHIGAN STREET NE
GRAND RAPIDS,  MI  49503
Correspondent Contact JOSEPH B MAROGIL
Regulation Number878.5900
Classification Product Code
GAX  
Date Received08/20/1985
Decision Date 10/10/1985
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
Recalls CDRH Recalls
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