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FDA 510(k)

STRATAPULSE TS AND STRATAPULSE

K-Number: K090837 · 2009-06-17

ApplicantAdvanced Medical Photonics
Decision Date2009-06-17
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STRATAPULSE TS AND STRATAPULSE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Photonics. It received FDA 510(k) clearance on 2009-06-17 under 510(k) number K090837. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATAPULSE TS AND STRATAPULSE?

STRATAPULSE TS AND STRATAPULSE is a medical device that received FDA 510(k) clearance on 2009-06-17. The listed applicant is Advanced Medical Photonics. The 510(k) number is K090837.

When did STRATAPULSE TS AND STRATAPULSE receive FDA 510(k) clearance?

STRATAPULSE TS AND STRATAPULSE received FDA 510(k) clearance on 2009-06-17, under 510(k) number K090837.

Who is the listed applicant for STRATAPULSE TS AND STRATAPULSE?

The FDA 510(k) record lists Advanced Medical Photonics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRATAPULSE TS AND STRATAPULSE?

The FDA product code for STRATAPULSE TS AND STRATAPULSE is ONF.

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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.

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