The following data is part of a premarket notification filed by Calgon Vestal Div. with the FDA for Kaltostat Fortex Wound Dressing.
| Device ID | K921009 |
| 510k Number | K921009 |
| Device Name: | KALTOSTAT FORTEX WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | CALGON VESTAL DIV. P.O. BOX 147 St.louis, MO 63166 -0147 |
| Contact | Micheal Ebers |
| Correspondent | Micheal Ebers CALGON VESTAL DIV. P.O. BOX 147 St.louis, MO 63166 -0147 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-03 |
| Decision Date | 1992-05-29 |