The following data is part of a premarket notification filed by Calgon Corp. with the FDA for Corassist Wound Dressing.
| Device ID | K943364 |
| 510k Number | K943364 |
| Device Name: | CORASSIST WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | CALGON CORP. P.O. BOX 147 St. Louis, MO 63167 -0147 |
| Contact | Anne Schmitt |
| Correspondent | Anne Schmitt CALGON CORP. P.O. BOX 147 St. Louis, MO 63167 -0147 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-13 |
| Decision Date | 1994-08-03 |