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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K871270
Device Name PERFORM DENTURE BASE RESIN
Applicant
Ipco Corp.
1025 Westchester Ave.
White Plains,  NY  10604
Applicant Contact LEONARD L WOLFSON
Correspondent
Ipco Corp.
1025 Westchester Ave.
White Plains,  NY  10604
Correspondent Contact LEONARD L WOLFSON
Regulation Number872.3690
Classification Product Code
EBF  
Date Received03/31/1987
Decision Date 05/29/1987
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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