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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K863504
Device Name OBSTETRICAL KIT
Applicant
Dyna-Med
One International Blvd.
Brewster,  NY  10509
Applicant Contact MARVIN D SCHATTNER
Correspondent
Dyna-Med
One International Blvd.
Brewster,  NY  10509
Correspondent Contact MARVIN D SCHATTNER
Date Received09/09/1986
Decision Date 10/22/1986
Decision Substantially Equivalent - With Drug (SESD)
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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