The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Contreet Foam Cavity Dressing With Silver, Model 9628 (2x4 In.).
| Device ID | K033869 |
| 510k Number | K033869 |
| Device Name: | CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) |
| Classification | Dressing, Wound, Drug |
| Applicant | COLOPLAST CORP. 1940 COMMERCE DR. North Mankato, MN 56003 |
| Contact | Elizabeth Boots |
| Correspondent | Elizabeth Boots COLOPLAST CORP. 1940 COMMERCE DR. North Mankato, MN 56003 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-12-12 |
| Decision Date | 2004-05-17 |
| Summary: | summary |