The following data is part of a premarket notification filed by Hydrofera, Llc. with the FDA for Hydrofera Bacteristatic Nasal Dressing.
| Device ID | K983276 |
| 510k Number | K983276 |
| Device Name: | HYDROFERA BACTERISTATIC NASAL DRESSING |
| Classification | Balloon, Epistaxis |
| Applicant | HYDROFERA, LLC. 322 MAIN ST., SUITE 1101 Willimantic, CT 06226 |
| Contact | Heather S Bond |
| Correspondent | Heather S Bond HYDROFERA, LLC. 322 MAIN ST., SUITE 1101 Willimantic, CT 06226 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-17 |
| Decision Date | 1999-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925030053 | K983276 | 000 |
| 00821925030251 | K983276 | 000 |
| 00821925030237 | K983276 | 000 |
| 00821925030213 | K983276 | 000 |
| 00821925030176 | K983276 | 000 |
| 00821925030145 | K983276 | 000 |
| 00821925030046 | K983276 | 000 |
| 00821925030008 | K983276 | 000 |
| 00821925029989 | K983276 | 000 |
| 00821925030206 | K983276 | 000 |
| 00821925030220 | K983276 | 000 |
| 00821925030152 | K983276 | 000 |
| 00821925030138 | K983276 | 000 |
| 00821925030039 | K983276 | 000 |
| 00821925030015 | K983276 | 000 |
| 00821925029996 | K983276 | 000 |
| 00821925029972 | K983276 | 000 |
| 00821925029958 | K983276 | 000 |
| 00821925030244 | K983276 | 000 |
| 00821925029965 | K983276 | 000 |