The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Porex Nostril Retainers.
| Device ID | K981374 |
| 510k Number | K981374 |
| Device Name: | POREX NOSTRIL RETAINERS |
| Classification | Splint, Intranasal Septal |
| Applicant | POREX SURGICAL, INC. 4715 ROOSEVELT HWY. College Park, GA 30349 -2417 |
| Contact | Howard A Mercer |
| Correspondent | Howard A Mercer POREX SURGICAL, INC. 4715 ROOSEVELT HWY. College Park, GA 30349 -2417 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-16 |
| Decision Date | 1998-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327292336 | K981374 | 000 |
| 07613252083757 | K981374 | 000 |
| 07613252083740 | K981374 | 000 |
| 07613252083733 | K981374 | 000 |
| 07613252083726 | K981374 | 000 |
| 07613252083719 | K981374 | 000 |
| 07613252083702 | K981374 | 000 |
| 07613252083696 | K981374 | 000 |
| 07613252083689 | K981374 | 000 |
| 07613252083672 | K981374 | 000 |
| 07613252083764 | K981374 | 000 |
| 07613252083771 | K981374 | 000 |
| 07613252083788 | K981374 | 000 |
| 07613327292329 | K981374 | 000 |
| 07613327292312 | K981374 | 000 |
| 07613327292305 | K981374 | 000 |
| 07613327292299 | K981374 | 000 |
| 07613327292282 | K981374 | 000 |
| 07613327292275 | K981374 | 000 |
| 07613327292268 | K981374 | 000 |
| 07613327292251 | K981374 | 000 |
| 07613327292244 | K981374 | 000 |
| 07613252083665 | K981374 | 000 |