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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 K882883
Device Name C-MASK(FLAT)
Applicant
Promedica Products, Inc.
620 Newport Center Dr.
Suite 575
Newport Beach,  CA  92660
Applicant Contact LEE HAND
Correspondent
Promedica Products, Inc.
620 Newport Center Dr.
Suite 575
Newport Beach,  CA  92660
Correspondent Contact LEE HAND
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/11/1988
Decision Date 08/10/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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