The following data is part of a premarket notification filed by Pollak (intl.), Ltd. with the FDA for Umbicut.
| Device ID | K000227 |
| 510k Number | K000227 |
| Device Name: | UMBICUT |
| Classification | Clamp, Umbilical |
| Applicant | POLLAK (INTL.), LTD. HAMLACHA 20, INDUSTRIAL ZONE Rosh Ha'ayin, IL 48091 |
| Contact | Michael Porat |
| Correspondent | Michael Porat POLLAK (INTL.), LTD. HAMLACHA 20, INDUSTRIAL ZONE Rosh Ha'ayin, IL 48091 |
| Product Code | HFW |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-24 |
| Decision Date | 2000-04-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() UMBICUT 75835029 2463454 Dead/Cancelled |
Porat, Michael 1999-11-14 |