The following data is part of a premarket notification filed by Beiersdorf-jobt, Inc. with the FDA for Modification Of Cutinova Hydro Dressing.
| Device ID | K984595 |
| 510k Number | K984595 |
| Device Name: | MODIFICATION OF CUTINOVA HYDRO DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | BEIERSDORF-JOBT, INC. 5825 CARNEGIE BLVD. Charlotte, NC 28209 -4633 |
| Contact | Angelo R Periera |
| Correspondent | Angelo R Periera BEIERSDORF-JOBT, INC. 5825 CARNEGIE BLVD. Charlotte, NC 28209 -4633 |
| 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 | 1998-12-28 |
| Decision Date | 1999-03-01 |
| Summary: | summary |