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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Wound, Plastic
510(k) Number K922785
Device Name IRRIVAGE
Applicant
Autovage
1631 Citation Dr.
South Park,  PA  15129
Applicant Contact JOSEPH P RUDOLPH
Correspondent
Autovage
1631 Citation Dr.
South Park,  PA  15129
Correspondent Contact JOSEPH P RUDOLPH
Regulation Number878.4014
Classification Product Code
EYF  
Date Received06/09/1992
Decision Date 10/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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