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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name source, chemiluminescent light
510(k) Number K012070
Device Name ORALLITE COMPREHENSIVE EXAM TRAY
Applicant
TRYLON CORP.
970 WEST 190TH ST., SUITE 850
TORRANCE,  CA  90502 -1037
Applicant Contact MARTIN L LONKY
Correspondent
TRYLON CORP.
970 WEST 190TH ST., SUITE 850
TORRANCE,  CA  90502 -1037
Correspondent Contact MARTIN L LONKY
Regulation Number884.4530
Classification Product Code
MPU  
Date Received07/02/2001
Decision Date 11/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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