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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 K992604
Device Name HENRY SCHEIN SURGICAL MASK
Applicant
Mitsui Textile Corp.
1450 Broadway
New York,  NY  10018
Applicant Contact WILLIAM J BARONE
Correspondent
Mitsui Textile Corp.
1450 Broadway
New York,  NY  10018
Correspondent Contact WILLIAM J BARONE
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/03/1999
Decision Date 01/28/2000
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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