The following data is part of a premarket notification filed by Pci Technology with the FDA for Aqua Patch.
| Device ID | K973693 |
| 510k Number | K973693 |
| Device Name: | AQUA PATCH |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | PCI TECHNOLOGY 10969 SHADY TRAIL SUITE 101 Dallas, TX 75220 |
| Contact | Roger Liebelt |
| Correspondent | Roger Liebelt PCI TECHNOLOGY 10969 SHADY TRAIL SUITE 101 Dallas, TX 75220 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-26 |
| Decision Date | 1997-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00366977208680 | K973693 | 000 |
| 00366977206334 | K973693 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AQUA PATCH 86508365 4803431 Live/Registered |
Aqua Patch Road Materials, L.L.C. 2015-01-20 |
![]() AQUA PATCH 86257419 not registered Dead/Abandoned |
Maxam Equipment, Inc. 2014-04-21 |