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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 K931580
Device Name DISPOSABLE SURGICAL MASK (MODIFIED)
Applicant
Bam Corp., Ltd.
Wallpark Commercial Bldg.
Rm. 1604-05, 10-12 Chatham Ct.
Kowloon,  HK
Applicant Contact MARY MEJAES
Correspondent
Bam Corp., Ltd.
Wallpark Commercial Bldg.
Rm. 1604-05, 10-12 Chatham Ct.
Kowloon,  HK
Correspondent Contact MARY MEJAES
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/30/1993
Decision Date 05/02/1994
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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