The following data is part of a premarket notification filed by Syntheon Llc with the FDA for Enolok-for Endoscoped With 12.8>dia.dia. 11.5mm Shaft ,model Pel.
| Device ID | K080317 |
| 510k Number | K080317 |
| Device Name: | ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.DIA. 11.5MM SHAFT ,MODEL PEL |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | SYNTHEON LLC 7290 SW 42ND ST. Miami, FL 33155 |
| Contact | Al Weisenborn |
| Correspondent | Al Weisenborn SYNTHEON LLC 7290 SW 42ND ST. Miami, FL 33155 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-06 |
| Decision Date | 2008-04-29 |
| Summary: | summary |