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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K902770
Device Name PATIENT EXAMINATION GLOVE
Applicant
MASTRI LIENO, PT
JL. MANGGA BESAR RAYA
NO. 102-A
JAKARTA,  ID 10740
Applicant Contact MARGONO, IR
Correspondent
MASTRI LIENO, PT
JL. MANGGA BESAR RAYA
NO. 102-A
JAKARTA,  ID 10740
Correspondent Contact MARGONO, IR
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/21/1990
Decision Date 08/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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