The following data is part of a premarket notification filed by Calgon Vestal Div. with the FDA for Kaltostat Wound Dressing.
| Device ID | K910059 |
| 510k Number | K910059 |
| Device Name: | KALTOSTAT WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | CALGON VESTAL DIV. P.O. BOX 147 St.louis, MO 63166 -0147 |
| Contact | Michael Ebers |
| Correspondent | Michael Ebers CALGON VESTAL DIV. P.O. BOX 147 St.louis, MO 63166 -0147 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-09 |
| Decision Date | 1991-03-20 |