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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 K941096
Device Name ELECTRIC VACUM PUMP
Applicant
IMPACT INSTRUMENTATION, INC.
27 FAIRFIELD PL.
P.O. BOX 508
WEST CALDWELL,  NJ  07006 -0508
Applicant Contact LESLIE H SHERMAN
Correspondent
IMPACT INSTRUMENTATION, INC.
27 FAIRFIELD PL.
P.O. BOX 508
WEST CALDWELL,  NJ  07006 -0508
Correspondent Contact LESLIE H SHERMAN
Regulation Number878.4780
Classification Product Code
BTA  
Date Received03/07/1994
Decision Date 01/05/1995
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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