The following data is part of a premarket notification filed by Medchannel, Llc with the FDA for Easytac Anchor. Easytac Delivery System.
Device ID | K060494 |
510k Number | K060494 |
Device Name: | EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM |
Classification | Staple, Implantable |
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 | GDW |
CFR Regulation Number | 878.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-24 |
Decision Date | 2006-07-03 |
Summary: | summary |