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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dam, Rubber
510(k) Number K905470
Device Name STANDARD RUBBER DAM WITH OR WITHOUT FRAMES
Applicant
Elastomade Accessories Sdn Bhd
89 2nd Floor, Jalan Ss 15/4c
Subang Jaya
Petaling Jaya,  MY 47500
Applicant Contact KATHERINE OOI
Correspondent
Elastomade Accessories Sdn Bhd
89 2nd Floor, Jalan Ss 15/4c
Subang Jaya
Petaling Jaya,  MY 47500
Correspondent Contact KATHERINE OOI
Regulation Number872.6300
Classification Product Code
EIE  
Date Received12/06/1990
Decision Date 04/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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