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FDA 510(k)

STOP U (Packed Black USA), STOP U (Packed White USA)

K-Number: K182774 · 2019-06-19

Decision Date2019-06-19
Product CodePAY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STOP U (Packed Black USA), STOP U (Packed White USA) is the device name listed in this FDA 510(k) record. The listed applicant is Pollogen, Ltd.. It received FDA 510(k) clearance on 2019-06-19 under 510(k) 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. The listed applicant is Pollogen, Ltd.. The 510(k) number is K182774.

When did STOP U (Packed Black USA), STOP U (Packed White USA) receive FDA 510(k) clearance?

STOP U (Packed Black USA), STOP U (Packed White USA) received FDA 510(k) clearance on 2019-06-19, under 510(k) number K182774.

Who is the listed applicant for STOP U (Packed Black USA), STOP U (Packed White USA)?

The FDA 510(k) record lists Pollogen, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Pollogen, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 14 devices →

Related Devices (Code: PAY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.