The following data is part of a premarket notification filed by Medchannel, Llc with the FDA for Opticlean Lens Irrigator & Optidock Tissue Ligator.
| Device ID | K051700 |
| 510k Number | K051700 |
| Device Name: | OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | MEDCHANNEL, LLC 55 WORCESTER STREET #3 Boston, MA 02118 |
| Contact | Frederick Tobia |
| Correspondent | Frederick Tobia MEDCHANNEL, LLC 55 WORCESTER STREET #3 Boston, MA 02118 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-24 |
| Decision Date | 2005-08-15 |
| Summary: | summary |