The following data is part of a premarket notification filed by Enko Ltd. with the FDA for Debp.
| Device ID | K092783 |
| 510k Number | K092783 |
| Device Name: | DEBP |
| Classification | Pump, Breast, Powered |
| Applicant | ENKO LTD. 10006 SOKAK, NO.64, A.O.S.B. Cigli - Izmir, TR 35620 |
| Contact | Sinan Kazazoglu |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-09-10 |
| Decision Date | 2009-10-22 |
| Summary: | summary |