The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Dissector.
Device ID | K111020 |
510k Number | K111020 |
Device Name: | ATRICURE DISSECTOR |
Classification | Lamp, Surgical |
Applicant | ATRICURE, INC. 6217 CENTRE PARK DRIVE West Chester, OH 45069 |
Contact | James L Lucky |
Correspondent | James L Lucky ATRICURE, INC. 6217 CENTRE PARK DRIVE West Chester, OH 45069 |
Product Code | FTD |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-12 |
Decision Date | 2011-06-09 |
Summary: | summary |