The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Contreet-h Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 Cm X 10cm), 9613 (6x6 (15cm X 15cm).
| Device ID | K013525 |
| 510k Number | K013525 |
| Device Name: | CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) |
| 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 | 2001-10-23 |
| Decision Date | 2002-10-04 |
| Summary: | summary |