The following data is part of a premarket notification filed by Calgon Vestal Div. with the FDA for Hydrasorb Sterile Dressing.
Device ID | K931599 |
510k Number | K931599 |
Device Name: | HYDRASORB STERILE DRESSING |
Classification | Dressing, Wound And Burn, Occlusive |
Applicant | CALGON VESTAL DIV. 5035 MANCHESTER AVE. St. Louis, MO 63110 |
Contact | Anne L Schmitt |
Correspondent | Anne L Schmitt CALGON VESTAL DIV. 5035 MANCHESTER AVE. St. Louis, MO 63110 |
Product Code | MGP |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-01 |
Decision Date | 1993-07-08 |