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 |