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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K093835
Device Name BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN
Applicant
Bam Corp., Ltd.
Unit 1706, Tower 2, Grand Cntl
Plaza, #138 Shatin Rural
Committee Rd.,Shatin, N.T.,  HK
Applicant Contact MARY MEJAES
Correspondent
Bam Corp., Ltd.
Unit 1706, Tower 2, Grand Cntl
Plaza, #138 Shatin Rural
Committee Rd.,Shatin, N.T.,  HK
Correspondent Contact MARY MEJAES
Regulation Number878.4040
Classification Product Code
FYA  
Date Received12/15/2009
Decision Date 02/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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