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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K002060
Device Name NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL
Applicant
DONGKUK TECHCO RUBBER INDUSTRIES
3 PENANG ST.
7TH FL., MAYBAN TRUST BLDG.
PENANG,  MY 10200
Applicant Contact PETER PARK
Correspondent
DONGKUK TECHCO RUBBER INDUSTRIES
3 PENANG ST.
7TH FL., MAYBAN TRUST BLDG.
PENANG,  MY 10200
Correspondent Contact PETER PARK
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/06/2000
Decision Date 09/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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