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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Sound, Uterine
510(k) Number K760170
Device Name INTRAUTERINE SOUND, PLASTIC DISPOSABLE
Applicant
G.D. SEARLE AND CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
G.D. SEARLE AND CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.4530
Classification Product Code
HHM  
Date Received07/06/1976
Decision Date 07/19/1976
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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