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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 K880020
Device Name 3 IN 1 AUTOMATIC TOURNIQUET
Applicant
Systematics Mfg. & Tool Co., Inc.
1555-F Ocean Ave.
Bohemia,  NY  11716
Applicant Contact GUNTER BARTZ
Correspondent
Systematics Mfg. & Tool Co., Inc.
1555-F Ocean Ave.
Bohemia,  NY  11716
Correspondent Contact GUNTER BARTZ
Regulation Number878.5910
Classification Product Code
KCY  
Date Received01/05/1988
Decision Date 03/17/1988
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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