The following data is part of a premarket notification filed by Calgon Vestal Div. with the FDA for Kaltostat Wound Dressing.
Device ID | K904488 |
510k Number | K904488 |
Device Name: | KALTOSTAT WOUND DRESSING |
Classification | Dressing, Wound, Drug |
Applicant | CALGON VESTAL DIV. P.O. BOX 147 St.louis, MO 63166 -0147 |
Contact | Donna Godward |
Correspondent | Donna Godward 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 For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-02 |
Decision Date | 1990-12-12 |