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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 K951423
Device Name ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT
Applicant
Impact Instrumentation, Inc.
27 Fairfield Pl.
P.O. Box 508
West Caldwell,  NJ  07006
Applicant Contact LESLIE H SHERMAN
Correspondent
Impact Instrumentation, Inc.
27 Fairfield Pl.
P.O. Box 508
West Caldwell,  NJ  07006
Correspondent Contact LESLIE H SHERMAN
Regulation Number878.4780
Classification Product Code
BTA  
Date Received03/27/1995
Decision Date 04/18/1995
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
Predetermined Change
Control Plan Authorized		 No
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