The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Comfeel Purilon Gel,15g(3900)/comfeel Purilon Gel,25g(3903).
| Device ID | K971597 |
| 510k Number | K971597 |
| Device Name: | COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | COLOPLAST CORP. 6401 MEADOWS WEST DR. Fort Worth, TX 76132 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer COLOPLAST CORP. 6401 MEADOWS WEST DR. Fort Worth, TX 76132 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-01 |
| Decision Date | 1997-07-29 |
| Summary: | summary |