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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. W., #100
Arlington,  TX  76006
Applicant Contact HOWARD PENNEY
Correspondent
Sun Medical, Inc.
1179 Corporate Dr. W., #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
Predetermined Change
Control Plan Authorized		 No
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