The following data is part of a premarket notification filed by Promepla Sam with the FDA for Endoflow Ii - Irrigation, Warming And Suction System.
| Device ID | K152278 |
| 510k Number | K152278 |
| Device Name: | ENDOFLOW II - Irrigation, Warming And Suction System |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | PROMEPLA SAM 9 AVENUE ALBERT II Monaco, MC 98000 |
| Contact | Alexandre Bareille |
| Correspondent | Alexandre Bareille PROMEPLA SAM 9 AVENUE ALBERT II Monaco, MC 98000 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-12 |
| Decision Date | 2016-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700512956181 | K152278 | 000 |
| 03700512911067 | K152278 | 000 |
| 03700512921073 | K152278 | 000 |
| 03700512921080 | K152278 | 000 |
| 03700512921097 | K152278 | 000 |
| 03700512921103 | K152278 | 000 |
| 03700512921110 | K152278 | 000 |
| 03700512921127 | K152278 | 000 |
| 03700512921134 | K152278 | 000 |
| 03700512921059 | K152278 | 000 |
| 03700512921042 | K152278 | 000 |
| 03700512911036 | K152278 | 000 |
| 03700512922032 | K152278 | 000 |
| 03700512922049 | K152278 | 000 |
| 03700512922056 | K152278 | 000 |
| 03700512922063 | K152278 | 000 |
| 03700512922070 | K152278 | 000 |
| 03700512922087 | K152278 | 000 |
| 03700512955269 | K152278 | 000 |
| 03700512911029 | K152278 | 000 |
| 03700512921141 | K152278 | 000 |
| 03700512921158 | K152278 | 000 |
| 03700512921165 | K152278 | 000 |
| 03700512921660 | K152278 | 000 |
| 03700512921677 | K152278 | 000 |
| 03700512911692 | K152278 | 000 |
| 03700512921707 | K152278 | 000 |
| 03700512921813 | K152278 | 000 |
| 03700512921837 | K152278 | 000 |
| 03700512921844 | K152278 | 000 |
| 03700512921868 | K152278 | 000 |
| 03700512921646 | K152278 | 000 |
| 03700512921639 | K152278 | 000 |
| 03700512921615 | K152278 | 000 |
| 03700512921271 | K152278 | 000 |
| 03700512921547 | K152278 | 000 |
| 03700512921554 | K152278 | 000 |
| 03700512921561 | K152278 | 000 |
| 03700512921578 | K152278 | 000 |
| 03700512921585 | K152278 | 000 |
| 03700512911593 | K152278 | 000 |
| 03700512921608 | K152278 | 000 |
| 03700512921653 | K152278 | 000 |