The following data is part of a premarket notification filed by North American Sterilization & Packaging Co. with the FDA for Hydrogel Skin Dressing.
| Device ID | K962352 |
| 510k Number | K962352 |
| Device Name: | HYDROGEL SKIN DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | NORTH AMERICAN STERILIZATION & PACKAGING CO. 18 WHITE LAKE RD. P.O. BOX 558 Sparta, NJ 07871 |
| Contact | Charles E Meisch |
| Correspondent | Charles E Meisch NORTH AMERICAN STERILIZATION & PACKAGING CO. 18 WHITE LAKE RD. P.O. BOX 558 Sparta, NJ 07871 |
| 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 | 1996-06-18 |
| Decision Date | 1996-08-02 |