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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 K982428
Device Name CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)
Applicant
Innervision, Inc.
6258 Shady Grove Rd. E.
Memphis,  TN  38120
Applicant Contact FRANK M LEWIS
Correspondent
Innervision, Inc.
6258 Shady Grove Rd. E.
Memphis,  TN  38120
Correspondent Contact FRANK M LEWIS
Regulation Number884.1720
Classification Product Code
HET  
Date Received07/13/1998
Decision Date 10/09/1998
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
Predetermined Change
Control Plan Authorized		 No
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