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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 K860095
Device Name DIGIKIT NONPNEUMATIC TOURNIQUET
Applicant
ORTHOFAB, INC.
7464 IRVIN AVE. SOUTH
COTTAGE GROVE,  MN  55016
Applicant Contact THOMAS H BARROWS
Correspondent
ORTHOFAB, INC.
7464 IRVIN AVE. SOUTH
COTTAGE GROVE,  MN  55016
Correspondent Contact THOMAS H BARROWS
Regulation Number878.5910
Classification Product Code
KCY  
Date Received01/10/1986
Decision Date 01/24/1986
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
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