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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 K875172
Device Name DISPOSABLE SURGICAL FACE MASK
Applicant
IREMA USA LTD.
1441 MAIN ST.
SUITE 1100
SPRINGFIELD,  MA  01103
Applicant Contact ROBERT MEEROPOL
Correspondent
IREMA USA LTD.
1441 MAIN ST.
SUITE 1100
SPRINGFIELD,  MA  01103
Correspondent Contact ROBERT MEEROPOL
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/17/1987
Decision Date 01/22/1988
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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