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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K945794
Device Name DURAPHAT
Applicant
Inpharma
One Kneeland St.
Sch Box 58
Boxton,  MA  02111
Applicant Contact R E CLARK
Correspondent
Inpharma
One Kneeland St.
Sch Box 58
Boxton,  MA  02111
Correspondent Contact R E CLARK
Regulation Number872.3260
Classification Product Code
LBH  
Date Received11/25/1994
Decision Date 07/26/1995
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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