510(k) K080040
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 Aug 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
- Aug 25, 2008
- Date Received
- Jan 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
- 510(k)