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 |