Comfeel Purilon GEL,15G(3900)/COMFEEL Purilon GEL,25G(3903)
FDA 510(k) K971597 · Coloplast Corp.
510(k) numberK971597
Submission
- Device name
- Comfeel Purilon GEL,15G(3900)/COMFEEL Purilon GEL,25G(3903)
- Applicant
- Coloplast Corp.
Fort Worth, TX, US - Received
- May 1, 1997
- Decision date
- July 29, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NAE – Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4022
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Comfeel Purilon GEL,15G(3900)/COMFEEL Purilon GEL,25G(3903) cleared by the FDA?
Comfeel Purilon GEL,15G(3900)/COMFEEL Purilon GEL,25G(3903) (K971597) received a 510(k) decision of Substantially Equivalent on July 29, 1997, 89 days after the submission was received.
What is the product code of K971597?
The FDA product code is NAE – Dressing, Wound, Hydrogel Without Drug And/Or Biologic, a Class I (low risk) device regulated under 21 CFR 878.4022.