The following data is part of a premarket notification filed by Acacia Laboratories, Inc. with the FDA for Sterigauze Gel Dressing.
| Device ID | K952419 |
| 510k Number | K952419 |
| Device Name: | STERIGAUZE GEL DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | ACACIA LABORATORIES, INC. 1719 SOUTH GRAND AVE. Santa Ana, CA 92705 -4808 |
| Contact | Ben Walthall |
| Correspondent | Ben Walthall ACACIA LABORATORIES, INC. 1719 SOUTH GRAND AVE. Santa Ana, CA 92705 -4808 |
| 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 | 1995-05-23 |
| Decision Date | 1995-07-26 |