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510(k) K080040

ORTHO ALL-FLEX DIAPHRAGM by Johnson & Johnson Produtos Profissionais Ltda. — Product Code HDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2008
Date Received
January 7, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diaphragm, Contraceptive (And Accessories)
Device Class
Class II
Regulation Number
884.5350
Review Panel
OB
Submission Type

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  • K800162 — ONCE TM (February 11, 1980)