The following data is part of a premarket notification filed by Coaptech Llc with the FDA for Puma-g System.
| Device ID | K183057 |
| 510k Number | K183057 |
| Device Name: | PUMA-G System |
| Classification | Tube, Gastro-enterostomy |
| Applicant | CoapTech LLC 8 Market Pl., Suite 804 Baltimore, MD 21202 |
| Contact | Jack Kent |
| Correspondent | Jack Kent CoapTech LLC 8 Market Pl., Suite 804 Baltimore, MD 21202 |
| Product Code | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-02 |
| Decision Date | 2019-04-10 |