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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Lock, Wire, And Ligature, Intraoral
510(k) Number K990212
Device Name LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00
Applicant
Doctor'S Research Group, Inc.
143 Wolcott Rd.
Wolcott,  CT  06716
Applicant Contact RICHARD DESLAURIERS
Correspondent
Doctor'S Research Group, Inc.
143 Wolcott Rd.
Wolcott,  CT  06716
Correspondent Contact RICHARD DESLAURIERS
Regulation Number872.4600
Classification Product Code
DYX  
Date Received01/22/1999
Decision Date 09/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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