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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K903534
Device Name SURGEON'S (SURGICAL) GLOVES
Applicant
Straitscom
C/O Bennett & Company, Inc.
13560 Brighton Dam Rd.
Clarksville,  MD  21029
Applicant Contact DEAN BARLOW
Correspondent
Straitscom
C/O Bennett & Company, Inc.
13560 Brighton Dam Rd.
Clarksville,  MD  21029
Correspondent Contact DEAN BARLOW
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/06/1990
Decision Date 08/17/1990
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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