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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 K926597
Device Name LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Applicant
Optimed Technologies, Inc.
1411 N. Batavia St.
Suite 114
Orange,  CA  92667
Applicant Contact RONALD J EHMSEN
Correspondent
Optimed Technologies, Inc.
1411 N. Batavia St.
Suite 114
Orange,  CA  92667
Correspondent Contact RONALD J EHMSEN
Regulation Number884.1720
Classification Product Code
HET  
Date Received04/24/1992
Decision Date 07/12/1994
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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