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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 K892061
Device Name GRAND GUARD SURGICAL GLOVES
Applicant
Galaxy Intl., Inc.
200 S. Main St.
Continental Bank Bldg.Ste 1121
Salt Lake City,  UT  84101
Applicant Contact MING CHENG
Correspondent
Galaxy Intl., Inc.
200 S. Main St.
Continental Bank Bldg.Ste 1121
Salt Lake City,  UT  84101
Correspondent Contact MING CHENG
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/30/1989
Decision Date 05/23/1989
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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