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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 K904645
Device Name HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM)
Applicant
HALL MEDICAL LABORATORIES
5751 RICHARDS CIRCLE
SHAWNEE,  KS  66216
Applicant Contact JOHN E HALL
Correspondent
HALL MEDICAL LABORATORIES
5751 RICHARDS CIRCLE
SHAWNEE,  KS  66216
Correspondent Contact JOHN E HALL
Regulation Number884.1720
Classification Product Code
HET  
Date Received10/11/1990
Decision Date 02/26/1991
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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