The following data is part of a premarket notification filed by Calgon Vestal Div. with the FDA for Kaltostat Wound Packing.
| Device ID | K892868 |
| 510k Number | K892868 |
| Device Name: | KALTOSTAT WOUND PACKING |
| Classification | Dressing, Wound, Drug |
| Applicant | CALGON VESTAL DIV. 5035 MANCHESTER AVE. St. Louis, MO 63110 |
| Contact | Richard C Jente |
| Correspondent | Richard C Jente CALGON VESTAL DIV. 5035 MANCHESTER AVE. St. Louis, MO 63110 |
| 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 | 1989-04-19 |
| Decision Date | 1989-07-14 |