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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Film, X-Ray
510(k) Number K853451
Device Name TROLL-BITE
Applicant
Trollplast, Inc.
P.O. Box 1703
New Milford,  CT  06776
Applicant Contact GUNILLA K HORROCKS
Correspondent
Trollplast, Inc.
P.O. Box 1703
New Milford,  CT  06776
Correspondent Contact GUNILLA K HORROCKS
Regulation Number872.1905
Classification Product Code
EGZ  
Date Received08/16/1985
Decision Date 01/21/1986
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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