The following data is part of a premarket notification filed by Calgon Vestal Div. with the FDA for Fortex(tm) Wound Dressing.
Device ID | K914314 |
510k Number | K914314 |
Device Name: | FORTEX(TM) WOUND DRESSING |
Classification | Bandage, Liquid |
Applicant | CALGON VESTAL DIV. P.O. BOX 147 St.louis, MO 63166 -0147 |
Contact | Anne L Schmitt |
Correspondent | Anne L Schmitt CALGON VESTAL DIV. P.O. BOX 147 St.louis, MO 63166 -0147 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-26 |
Decision Date | 1991-10-23 |