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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Gynecological
510(k) Number K011488
Device Name SPIRABRUSH CX BIOPSY INSTRUMENT
Applicant
TRYLON CORP.
970 WEST 190TH ST., SUITE 850
TORRANCE,  CA  90502 -1037
Applicant Contact MARTIN LONKY
Correspondent
TRYLON CORP.
970 WEST 190TH ST., SUITE 850
TORRANCE,  CA  90502 -1037
Correspondent Contact MARTIN LONKY
Regulation Number884.4530
Classification Product Code
HFB  
Subsequent Product Code
HHT  
Date Received05/15/2001
Decision Date 02/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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