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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K034015
Device Name EARLOOP PROCEDURE MASK
Applicant
Medipack Medical Packaging Mfg. Co.
1202 S. Rte. 31
Mc Henry,  IL  60050
Applicant Contact ANTONIO L GIACCIO
Correspondent
Medipack Medical Packaging Mfg. Co.
1202 S. Rte. 31
Mc Henry,  IL  60050
Correspondent Contact ANTONIO L GIACCIO
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/24/2003
Decision Date 02/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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