510(k) K121822
K121822 is an FDA 510(k) premarket notification submitted by American Surgical Company, LLC for the device "DELICOT". The FDA issued a decision of Substantially Equivalent on September 10, 2012. The device falls under product code HBA (Neurosurgical Paddie), a Class II device regulated under 21 CFR 882.4700. American Surgical Company, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 10, 2012
- Date Received
- June 21, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurosurgical Paddie
- Device Class
- Class II
- Regulation Number
- 882.4700
- Review Panel
- NE
- Submission Type