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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 K780988
Device Name DEVIN-NESTOR PNEUMATIC TOURNIQUET
Applicant
Nestor Engineering Associates, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Nestor Engineering Associates, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.5910
Classification Product Code
KCY  
Date Received06/14/1978
Decision Date 10/03/1978
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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