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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air-Conduction, Prescription
510(k) Number K891556
Device Name EXAM GLOVES (VINYL) MFG. GLORIOUS WEALTH CO.
Applicant
Green Light Import Export Co., Inc.
111 Briny Av #707
Pompano Beach,  FL  33062
Applicant Contact GORAN PECOTIC
Correspondent
Green Light Import Export Co., Inc.
111 Briny Av #707
Pompano Beach,  FL  33062
Correspondent Contact GORAN PECOTIC
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/17/1989
Decision Date 04/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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