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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 K963391
Device Name SPECULITE
Applicant
Trylon Corp.
23268 Atlantis Way
Monarch Beach,  CA  92629
Applicant Contact A. THOMAS DOYLE
Correspondent
Trylon Corp.
23268 Atlantis Way
Monarch Beach,  CA  92629
Correspondent Contact A. THOMAS DOYLE
Regulation Number884.4530
Classification Product Code
MPU  
Date Received08/28/1996
Decision Date 12/12/1997
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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