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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, Ward Use, Portable, Ac-Powered
510(k) Number K133196
Device Name IMPACT MODEL 323 ASPIRATOR
Applicant
Impact Instrumentation, Inc.
27 Fairfield Pl.
P.O. Box 508
West Caldwell,  NJ  07006
Applicant Contact ALAN GIORDANO
Correspondent
Impact Instrumentation, Inc.
27 Fairfield Pl.
P.O. Box 508
West Caldwell,  NJ  07006
Correspondent Contact ALAN GIORDANO
Regulation Number878.4780
Classification Product Code
JCX  
Date Received10/17/2013
Decision Date 03/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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