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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K982377
Device Name OPC LOWWEAR PORCELAIN
Applicant
Jeneric/Pentron, Inc.
53 N. Plains Industrial Rd.
P.O. Box 724
Wallingford,  CT  06492
Applicant Contact MURRAY G GAMBERG
Correspondent
Jeneric/Pentron, Inc.
53 N. Plains Industrial Rd.
P.O. Box 724
Wallingford,  CT  06492
Correspondent Contact MURRAY G GAMBERG
Regulation Number872.6660
Classification Product Code
EIH  
Date Received07/08/1998
Decision Date 08/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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