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510(k) K080040

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

K080040 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Produtos Profissionais Ltda. for the device "ORTHO ALL-FLEX DIAPHRAGM". The FDA issued a decision of Substantially Equivalent on August 25, 2008. The device falls under product code HDW (Diaphragm, Contraceptive (And Accessories)), a Class II device regulated under 21 CFR 884.5350.

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

Other clearances for product code HDW

  • K140305 — CAYA CONTOURED DIAPHRAGM (August 26, 2014)
  • K063223 — MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL (January 23, 2008)
  • K800162 — ONCE TM (February 11, 1980)

FDA data resources