The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Nu-gel Island Wound Dressing.
Device ID | K932336 |
510k Number | K932336 |
Device Name: | NU-GEL ISLAND WOUND DRESSING |
Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
Applicant | JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington, TX 76004 -3130 |
Contact | Linda G Hill |
Correspondent | Linda G Hill JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington, TX 76004 -3130 |
Product Code | MGQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-14 |
Decision Date | 1994-02-09 |