The following data is part of a premarket notification filed by American Surgical Company, Llc with the FDA for Delicot.
Device ID | K121822 |
510k Number | K121822 |
Device Name: | DELICOT |
Classification | Neurosurgical Paddie |
Applicant | AMERICAN SURGICAL COMPANY, LLC 82 SANDERSON AVENUE Lynn, MA 01902 |
Contact | Erik Piasio |
Correspondent | Erik Piasio AMERICAN SURGICAL COMPANY, LLC 82 SANDERSON AVENUE Lynn, MA 01902 |
Product Code | HBA |
CFR Regulation Number | 882.4700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-21 |
Decision Date | 2012-09-10 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DELICOT 85051913 3904263 Live/Registered |
AMERICAN SURGICAL COMPANY, LLC 2010-06-01 |