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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 K952038
Device Name CLEAN-CUFF
Applicant
INSTRUMED, INC.
11818 N. CREEK PARKWAY NORTH
SUITE 105
BOTHELL,  WA  98011
Applicant Contact JERRY L SPENCE
Correspondent
INSTRUMED, INC.
11818 N. CREEK PARKWAY NORTH
SUITE 105
BOTHELL,  WA  98011
Correspondent Contact JERRY L SPENCE
Regulation Number878.5910
Classification Product Code
KCY  
Date Received05/01/1995
Decision Date 07/11/1995
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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