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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Single Patient Use, Portable, Nonpowered
510(k) Number K801766
Device Name JACKSON-PRATT LARGE VOL. CLOSED WOUND
Applicant
AMERICAN HEYER SCHULTE
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN HEYER SCHULTE
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4680
Classification Product Code
GCY  
Date Received07/28/1980
Decision Date 08/20/1980
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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