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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 K883658
Device Name I-SPOSE EYE SHIELD
Applicant
PRODUCTS FOR MEDICINE
17853 SANTIAGO #107-347
VILLA PARK,  CA  92667
Applicant Contact FRED FECHTMAN
Correspondent
PRODUCTS FOR MEDICINE
17853 SANTIAGO #107-347
VILLA PARK,  CA  92667
Correspondent Contact FRED FECHTMAN
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/26/1988
Decision Date 10/25/1988
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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