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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 K963568
Device Name MASK SURGICAL
Applicant
The Innovative Approach, Corp.
422 Italia St.
Hato Rey,  PR  00917
Applicant Contact ELISA N PEREZ
Correspondent
The Innovative Approach, Corp.
422 Italia St.
Hato Rey,  PR  00917
Correspondent Contact ELISA N PEREZ
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/05/1996
Decision Date 02/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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