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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 K080040
Device Name ORTHO ALL-FLEX DIAPHRAGM
Applicant
Johnson & Johnson Produtos Profissionais Ltda.
220 River Rd.
Claremont,  NH  03743 -5647
Applicant Contact WILLIAM GREENROSE
Correspondent
Johnson & Johnson Produtos Profissionais Ltda.
220 River Rd.
Claremont,  NH  03743 -5647
Correspondent Contact WILLIAM GREENROSE
Regulation Number884.5350
Classification Product Code
HDW  
Date Received01/07/2008
Decision Date 08/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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