The following data is part of a premarket notification filed by Ludlow Technical Products with the FDA for Ad-heal Hydrogel Dressing, Various Sizes.
| Device ID | K972646 |
| 510k Number | K972646 |
| Device Name: | AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | LUDLOW TECHNICAL PRODUCTS TWO LUDLOW PARK Chicopee, MA 01022 |
| Contact | Patrick A Malia |
| Correspondent | Patrick A Malia LUDLOW TECHNICAL PRODUCTS TWO LUDLOW PARK Chicopee, MA 01022 |
| 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 | 1997-07-15 |
| Decision Date | 1997-08-21 |