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 |