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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 K903596
Device Name ESPI REDUCER SLEEVE, #8415
Applicant
DIXON MEDICAL, INC.
1534 S. JOHNSON FERRY RD.
ATLANTA,  GA  30319
Applicant Contact WILLIAM C DIXON
Correspondent
DIXON MEDICAL, INC.
1534 S. JOHNSON FERRY RD.
ATLANTA,  GA  30319
Correspondent Contact WILLIAM C DIXON
Regulation Number884.1720
Classification Product Code
HET  
Date Received08/08/1990
Decision Date 09/12/1990
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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