510(k) K090167
K090167 is an FDA 510(k) premarket notification submitted by Philips Electronics UK Limited for the device "PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER,". The FDA issued a decision of Substantially Equivalent on June 18, 2009. The device falls under product code KKO (Ring, Teething, Fluid-Filled), a Class II device regulated under 21 CFR 872.5550. Philips Electronics UK Limited has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2009
- Date Received
- January 22, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ring, Teething, Fluid-Filled
- Device Class
- Class II
- Regulation Number
- 872.5550
- Review Panel
- DE
- Submission Type