NXH — Nursing Pad, Cohesive Gel Class I
FDA product code NXH covers "Nursing Pad, Cohesive Gel", a Class I medical device regulated under 21 CFR 880.5630. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NXH
- Device Class
- Class I
- Regulation Number
- 880.5630
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
Intended to relieve nipples that are sore and cracked from breast feeding.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K052858 | puronxy | SOOTHIES GEL PADS | February 9, 2006 |