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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K872745
Device Name VINYL POLYSILOXANE IMPRESSION SYSTEM
Applicant
Crown Delta Corp.
1550 Front St.
Yorktown Heights,  NY  10598
Applicant Contact LAURENCE COLIN
Correspondent
Crown Delta Corp.
1550 Front St.
Yorktown Heights,  NY  10598
Correspondent Contact LAURENCE COLIN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received07/13/1987
Decision Date 07/21/1987
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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