The following data is part of a premarket notification filed by Pentax Medical Company with the FDA for Pentex Ec-3890li.
| Device ID | K093037 |
| 510k Number | K093037 |
| Device Name: | PENTEX EC-3890LI |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | PENTAX MEDICAL COMPANY 102 CHESTNUT RIDGE RD. Montvale, NJ 07645 -1856 |
| Contact | Lisa Lancia |
| Correspondent | Lisa Lancia PENTAX MEDICAL COMPANY 102 CHESTNUT RIDGE RD. Montvale, NJ 07645 -1856 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-29 |
| Decision Date | 2009-12-28 |
| Summary: | summary |