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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 K845006
Device Name SUN MEDICAL LAMINARIA CERVICAL DILATOR
Applicant
SUN MEDICAL, INC.
1179 CORPORATE DR. WEST, #100
ARLINGTON,  TX  76006
Applicant Contact HOWARD PENNEY
Correspondent
SUN MEDICAL, INC.
1179 CORPORATE DR. WEST, #100
ARLINGTON,  TX  76006
Correspondent Contact HOWARD PENNEY
Regulation Number884.4260
Classification Product Code
HDY  
Date Received12/26/1984
Decision Date 05/01/1985
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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