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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 K952628
Device Name ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS
Applicant
Elastomade Accessories Sdn Bhd
89 2nd Floor, Jalan Ss 15/4c
Subang Jaya
Petaling Jaya,  MY 47500
Applicant Contact ONG L MAU
Correspondent
Elastomade Accessories Sdn Bhd
89 2nd Floor, Jalan Ss 15/4c
Subang Jaya
Petaling Jaya,  MY 47500
Correspondent Contact ONG L MAU
Regulation Number872.6300
Classification Product Code
EIE  
Date Received06/08/1995
Decision Date 10/19/1995
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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