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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diaphragm, Contraceptive (And Accessories)
510(k) Number K800162
Device Name ONCE TM
Applicant
G.D. SEARLE AND CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
G.D. SEARLE AND CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.5350
Classification Product Code
HDW  
Date Received01/25/1980
Decision Date 02/11/1980
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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