510(k) K052858
K052858 is an FDA 510(k) premarket notification submitted by Puronxy, Inc. for the device "SOOTHIES GEL PADS". The FDA issued a decision of Substantially Equivalent on February 9, 2006. The device falls under product code NXH (Nursing Pad, Cohesive Gel), a Class I device regulated under 21 CFR 880.5630.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2006
- Date Received
- October 11, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nursing Pad, Cohesive Gel
- Device Class
- Class I
- Regulation Number
- 880.5630
- Review Panel
- HO
- Submission Type
Intended to relieve nipples that are sore and cracked from breast feeding.