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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K955119
Device Name SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
Applicant
Symbiosis Corp.
8600 NW 41 St.
Miami,  FL  33166
Applicant Contact JAMES R STITT
Correspondent
Symbiosis Corp.
8600 NW 41 St.
Miami,  FL  33166
Correspondent Contact JAMES R STITT
Regulation Number884.1690
Classification Product Code
HIH  
Date Received11/09/1995
Decision Date 01/18/1996
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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