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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 K820330
Device Name IMPACT, MODEL E-12
Applicant
IMPACT INSTRUMENTATION, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
IMPACT INSTRUMENTATION, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4780
Classification Product Code
JCX  
Date Received02/08/1982
Decision Date 02/23/1982
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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