NTX — Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) Class I
FDA product code NTX covers "Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)", 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
- NTX
- Device Class
- Class I
- Regulation Number
- 880.5630
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
A NURSING PAD CONSISTING OF A POLYURETHANE PAD WITH GLYCERIN USED TO RELIEVE NIPPLES THAT ARE SORE AND CRACKED FROM BREASTFEEDING.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K031660 | ferris mfg | FERRIS POLYMEM STERILE BREAST PAD | February 22, 2005 |