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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, Operating-Room, Wall Vacuum Powered
510(k) Number K820337
Device Name IMPACT, MODEL 303
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 Number880.6740
Classification Product Code
GCX  
Date Received02/08/1982
Decision Date 03/02/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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