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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Specialized Obstetric-Gynecologic
510(k) Number K971277
Device Name SAFE-T-CLAMP
Applicant
TALON MEDICAL, LTD.
18160 HWY., 281 NORTH,#108-200
SAN ANTONIO,  TX  78232
Applicant Contact DAVID COCKE
Correspondent
TALON MEDICAL, LTD.
18160 HWY., 281 NORTH,#108-200
SAN ANTONIO,  TX  78232
Correspondent Contact DAVID COCKE
Regulation Number884.4530
Classification Product Code
KNA  
Date Received04/07/1997
Decision Date 05/20/1997
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
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