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FDA 510(k)

MBI PD-103 SL; MBI PD-103 SH

K-Number: K011427 · 2001-08-31

ApplicantMills Biopharmaceuticals, Inc.
Decision Date2001-08-31
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MBI PD-103 SL; MBI PD-103 SH is the device name listed in this FDA 510(k) record. The listed applicant is Mills Biopharmaceuticals, Inc.. It received FDA 510(k) clearance on 2001-08-31 under 510(k) number K011427. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MBI PD-103 SL; MBI PD-103 SH?

MBI PD-103 SL; MBI PD-103 SH is a medical device that received FDA 510(k) clearance on 2001-08-31. The listed applicant is Mills Biopharmaceuticals, Inc.. The 510(k) number is K011427.

When did MBI PD-103 SL; MBI PD-103 SH receive FDA 510(k) clearance?

MBI PD-103 SL; MBI PD-103 SH received FDA 510(k) clearance on 2001-08-31, under 510(k) number K011427.

Who is the listed applicant for MBI PD-103 SL; MBI PD-103 SH?

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

What is the FDA product code for MBI PD-103 SL; MBI PD-103 SH?

The FDA product code for MBI PD-103 SL; MBI PD-103 SH is KXK.

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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.

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