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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, cervical, hygroscopic-laminaria
510(k) Number K782067
Device Name DILATOR, MIZUTANI LAMINARIA TENT
Applicant
BRITISH MARKETING ENT., LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BRITISH MARKETING ENT., LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.4260
Classification Product Code
HDY  
Date Received12/13/1978
Decision Date 01/03/1979
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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