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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K953364
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 Number884.1720
Classification Product Code
HET  
Subsequent Product Codes
HEX   KZF  
Date Received07/17/1995
Decision Date 12/08/1995
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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