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 |