The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Sween Woun'dres.
| Device ID | K983042 |
| 510k Number | K983042 |
| Device Name: | SWEEN WOUN'DRES |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | COLOPLAST CORP. 1940 COMMERCE DR. North Mankato, MN 56003 |
| Contact | Harvey M Arbit |
| Correspondent | Harvey M Arbit COLOPLAST CORP. 1940 COMMERCE DR. North Mankato, MN 56003 |
| 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 | 1998-08-31 |
| Decision Date | 1998-11-25 |
| Summary: | summary |