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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Vaginal, Nonmetal, Fiberoptic
510(k) Number K955790
Device Name PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY
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
HIC  
Subsequent Product Code
HHT  
Date Received12/22/1995
Decision Date 03/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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