STOP U (Packed Black USA), STOP U (Packed White USA)
K-Number: K182774 · 2019-06-19
ApplicantPollogen, Ltd.
Decision Date2019-06-19
Product CodePAY
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
STOP U (Packed Black USA), STOP U (Packed White USA) is a medical device manufactured by Pollogen, Ltd.. It received FDA 510(k) clearance on 2019-06-19 under approval number K182774. The device is classified under product code PAY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the STOP U (Packed Black USA), STOP U (Packed White USA)?
STOP U (Packed Black USA), STOP U (Packed White USA) is a medical device that received FDA 510(k) clearance on 2019-06-19. It is manufactured by Pollogen, Ltd.. The 510(k) number is K182774.
When was STOP U (Packed Black USA), STOP U (Packed White USA) approved by the FDA?
STOP U (Packed Black USA), STOP U (Packed White USA) received FDA 510(k) clearance on 2019-06-19, under approval number K182774.
What company makes STOP U (Packed Black USA), STOP U (Packed White USA)?
STOP U (Packed Black USA), STOP U (Packed White USA) is manufactured by Pollogen, Ltd..
What is the FDA product code for STOP U (Packed Black USA), STOP U (Packed White USA)?
The FDA product code for STOP U (Packed Black USA), STOP U (Packed White USA) is PAY.
Related Clinical Trials
Other Devices by Pollogen, Ltd.
Related Devices (Code: PAY)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.