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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 K910512
Device Name ACCUFLATE
Applicant
Instrumed, Inc.
11818 N. Creek Pkwy. N.
Suite 105
Bothell,  WA  98011
Applicant Contact JERRY L SPENCE
Correspondent
Instrumed, Inc.
11818 N. Creek Pkwy. N.
Suite 105
Bothell,  WA  98011
Correspondent Contact JERRY L SPENCE
Regulation Number878.5910
Classification Product Code
KCY  
Date Received02/05/1991
Decision Date 02/19/1991
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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