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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 K831116
Device Name INVAC W/VARIOUS MODELS
Applicant
Pmt
Box 464
Hopkins,  MN  55343
Applicant Contact Alfred A Iversen
Correspondent
Pmt
Box 464
Hopkins,  MN  55343
Correspondent Contact Alfred A Iversen
Regulation Number880.6740
Classification Product Code
GCX  
Date Received04/05/1983
Decision Date 08/12/1983
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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