STOP U (Packed Black USA), STOP U (Packed White USA)— 510(k) K182774

Name: FDA 510(k) clearance K182774
Creator: U.S. Food and Drug Administration
Published: 2019-06-19

Substantially Equivalent

Pollogen, Ltd.

FDA 510(k) clearance K182774 for STOP U (Packed Black USA), STOP U (Packed White USA), Substantially Equivalent on 2019-06-19. Applicant: Pollogen, Ltd.. Device class: 2.

Clearance details

Applicant: Pollogen, Ltd.
Product code: Code PAY
Device class: Class 2
Regulation: 21 CFR 878.4420
Advisory panel: General, Plastic Surgery
Date received: 2018-10-01
Decision date: 2019-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.