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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 K940718
Device Name INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS
Applicant
Innervision, Inc.
1755 Lynnfield Rd.
Suite 190
Memphis,  TN  38119
Applicant Contact FRANK M LEWIS
Correspondent
Innervision, Inc.
1755 Lynnfield Rd.
Suite 190
Memphis,  TN  38119
Correspondent Contact FRANK M LEWIS
Regulation Number884.1720
Classification Product Code
HET  
Date Received02/18/1994
Decision Date 07/22/1994
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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