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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 K903339
Device Name VIDEO ENDOSCOPE, RIGID
Applicant
MEDICAL DYNAMICS, INC.
99 INVERNESS DR., EAST
ENGLEWOOD,  CO  80112
Applicant Contact JO BREHM
Correspondent
MEDICAL DYNAMICS, INC.
99 INVERNESS DR., EAST
ENGLEWOOD,  CO  80112
Correspondent Contact JO BREHM
Regulation Number884.1720
Classification Product Code
HET  
Date Received07/25/1990
Decision Date 03/06/1991
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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