510(k) K151413
K151413 is an FDA 510(k) premarket notification submitted by Procter & Gamble for the device "Always/Tampax bladder supports". The FDA issued a decision of Substantially Equivalent on December 18, 2015. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575. Procter & Gamble has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2015
- Date Received
- May 27, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pessary, Vaginal
- Device Class
- Class II
- Regulation Number
- 884.3575
- Review Panel
- OB
- Submission Type