FDA 510(k)

BLUE SKY BIO PLAN, VERSION .38

K-Number: K090607 · 2009-04-22

Decision Date2009-04-22

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BLUE SKY BIO PLAN, VERSION .38 is the device name listed in this FDA 510(k) record. The listed applicant is Blue Sky Bio, LLC. It received FDA 510(k) clearance on 2009-04-22 under 510(k) number K090607. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLUE SKY BIO PLAN, VERSION .38?

BLUE SKY BIO PLAN, VERSION .38 is a medical device that received FDA 510(k) clearance on 2009-04-22. The listed applicant is Blue Sky Bio, LLC. The 510(k) number is K090607.

When did BLUE SKY BIO PLAN, VERSION .38 receive FDA 510(k) clearance?

BLUE SKY BIO PLAN, VERSION .38 received FDA 510(k) clearance on 2009-04-22, under 510(k) number K090607.

Who is the listed applicant for BLUE SKY BIO PLAN, VERSION .38?

The FDA 510(k) record lists Blue Sky Bio, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLUE SKY BIO PLAN, VERSION .38?

The FDA product code for BLUE SKY BIO PLAN, VERSION .38 is LLZ.

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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.