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FDA 510(k)

CELLU M6 KEYMODULE I

K-Number: K053225 · 2006-11-06

ApplicantLpg One, Inc.
Decision Date2006-11-06
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CELLU M6 KEYMODULE I is the device name listed in this FDA 510(k) record. The listed applicant is Lpg One, Inc.. It received FDA 510(k) clearance on 2006-11-06 under 510(k) number K053225. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELLU M6 KEYMODULE I?

CELLU M6 KEYMODULE I is a medical device that received FDA 510(k) clearance on 2006-11-06. The listed applicant is Lpg One, Inc.. The 510(k) number is K053225.

When did CELLU M6 KEYMODULE I receive FDA 510(k) clearance?

CELLU M6 KEYMODULE I received FDA 510(k) clearance on 2006-11-06, under 510(k) number K053225.

Who is the listed applicant for CELLU M6 KEYMODULE I?

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

What is the FDA product code for CELLU M6 KEYMODULE I?

The FDA product code for CELLU M6 KEYMODULE I is ISA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: ISA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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