The following data is part of a premarket notification filed by Brady Medical Products Co. with the FDA for Brady Medical Products Transorb Wound Dressing.
Device ID | K935848 |
510k Number | K935848 |
Device Name: | BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING |
Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
Applicant | BRADY MEDICAL PRODUCTS CO. 727 W. GLENDALE AVE. P.O. BOX 571 Milwaukee, WI 53201 |
Contact | Terri Tessmann |
Correspondent | Terri Tessmann BRADY MEDICAL PRODUCTS CO. 727 W. GLENDALE AVE. P.O. BOX 571 Milwaukee, WI 53201 |
Product Code | MGQ |
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 | 1993-12-08 |
Decision Date | 1994-02-15 |