The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Modification To Woun'dres.
| Device ID | K991202 |
| 510k Number | K991202 |
| Device Name: | MODIFICATION TO WOUN'DRES |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | COLOPLAST CORP. 1940 COMMERCE DR. P.O. BOX 8300 North Mankato, MN 56003 -8300 |
| Contact | Harvey M Arbit |
| Correspondent | Harvey M Arbit COLOPLAST CORP. 1940 COMMERCE DR. P.O. BOX 8300 North Mankato, MN 56003 -8300 |
| 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 | 1999-03-22 |
| Decision Date | 1999-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00311701161564 | K991202 | 000 |
| 00311701161526 | K991202 | 000 |