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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
510(k) Number K772220
Device Name PROBE, COAGULATION ACCESSORY
Applicant
KLI
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
KLI
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.4160
Classification Product Code
KNF  
Date Received12/05/1977
Decision Date 12/13/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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