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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 K903212
Device Name LATEX SURGICAL STERILE GLOVES
Applicant
Mirage Medical & Chemical, Inc.
15932 W. State Rd. 84 #
151
Sunrise,  FL  33326
Applicant Contact JOAQUIM M ROLA
Correspondent
Mirage Medical & Chemical, Inc.
15932 W. State Rd. 84 #
151
Sunrise,  FL  33326
Correspondent Contact JOAQUIM M ROLA
Regulation Number878.4460
Classification Product Code
KGO  
Date Received07/11/1990
Decision Date 08/01/1990
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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