The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Stentube Lacrimal Intubation Set.
| Device ID | K113118 |
| 510k Number | K113118 |
| Device Name: | STENTUBE LACRIMAL INTUBATION SET |
| Classification | Lacrimal Stents And Intubation Sets |
| Applicant | QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 |
| Contact | Amy Clendening-wheeler |
| Correspondent | Amy Clendening-wheeler QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 |
| Product Code | OKS |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-21 |
| Decision Date | 2012-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10634624715520 | K113118 | 000 |
| 10634624815527 | K113118 | 000 |