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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 Tray, Resin
510(k) Number K853093
Device Name PSP TEMP - TRAY
Applicant
Psp Dental Co., Ltd.
3-5 Dylan Rd.
Belvedere, Kent,  GB DA17 5QS
Correspondent
Psp Dental Co., Ltd.
3-5 Dylan Rd.
Belvedere, Kent,  GB DA17 5QS
Regulation Number872.3670
Classification Product Code
EBH  
Date Received07/23/1985
Decision Date 09/06/1985
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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