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FDA 510(k)

JAZZ Passer Band

K-Number: K171881 · 2017-08-08

Decision Date2017-08-08
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JAZZ Passer Band is a medical device manufactured by Implanet, S.A.. It received FDA 510(k) clearance on 2017-08-08 under approval number K171881. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAZZ Passer Band?

JAZZ Passer Band is a medical device that received FDA 510(k) clearance on 2017-08-08. It is manufactured by Implanet, S.A.. The 510(k) number is K171881.

When was JAZZ Passer Band approved by the FDA?

JAZZ Passer Band received FDA 510(k) clearance on 2017-08-08, under approval number K171881.

What company makes JAZZ Passer Band?

JAZZ Passer Band is manufactured by Implanet, S.A..

What is the FDA product code for JAZZ Passer Band?

The FDA product code for JAZZ Passer Band is OWI.

Other Devices by Implanet, S.A.

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Related Devices (Code: OWI)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.