The following data is part of a premarket notification filed by Hydrofera, Llc. with the FDA for Hydrofera Bacteriostatic Wound Dressing.
| Device ID | K013462 |
| 510k Number | K013462 |
| Device Name: | HYDROFERA BACTERIOSTATIC WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | HYDROFERA, LLC. 322 MAIN ST., SUITE 1101 Willimantic, CT 06226 |
| Contact | Heather H Bond |
| Correspondent | Heather H Bond HYDROFERA, LLC. 322 MAIN ST., SUITE 1101 Willimantic, CT 06226 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-18 |
| Decision Date | 2002-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20854827008152 | K013462 | 000 |
| 10854827008346 | K013462 | 000 |
| 10854827008353 | K013462 | 000 |
| 20854827008060 | K013462 | 000 |
| 20854827008077 | K013462 | 000 |
| 20854827008084 | K013462 | 000 |
| 20854827008091 | K013462 | 000 |
| 20854827008107 | K013462 | 000 |
| 20854827008114 | K013462 | 000 |
| 20854827008121 | K013462 | 000 |
| 20854827008138 | K013462 | 000 |
| 20854827008145 | K013462 | 000 |
| 00854827008585 | K013462 | 000 |