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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K843750
Device Name APPARATUS, SUCTION, WARD USE, PORTAB-
Applicant
H.C.H. Products, Inc.
4169 Allendale Pkwy.
Blasdell,  NY  14219
Applicant Contact MANNING II
Correspondent
H.C.H. Products, Inc.
4169 Allendale Pkwy.
Blasdell,  NY  14219
Correspondent Contact MANNING II
Regulation Number878.4780
Classification Product Code
BTA  
Date Received09/25/1984
Decision Date 10/11/1984
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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