510(k) K183057
K183057 is an FDA 510(k) premarket notification submitted by Coaptech, LLC for the device "PUMA-G System". The FDA issued a decision of Substantially Equivalent on April 10, 2019. The device falls under product code KGC (Tube, Gastro-Enterostomy), a Class II device regulated under 21 CFR 876.5980. Coaptech, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2019
- Date Received
- November 2, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Gastro-Enterostomy
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type