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FDA 510(k)

AIA-PACK BRCA, ST AIA PACK BRCA

K-Number: K010796 · 2001-08-16

ApplicantTosoh Medics, Inc.
Decision Date2001-08-16
Product CodeMOI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AIA-PACK BRCA, ST AIA PACK BRCA is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Medics, Inc.. It received FDA 510(k) clearance on 2001-08-16 under 510(k) number K010796. The device is classified under product code MOI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIA-PACK BRCA, ST AIA PACK BRCA?

AIA-PACK BRCA, ST AIA PACK BRCA is a medical device that received FDA 510(k) clearance on 2001-08-16. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K010796.

When did AIA-PACK BRCA, ST AIA PACK BRCA receive FDA 510(k) clearance?

AIA-PACK BRCA, ST AIA PACK BRCA received FDA 510(k) clearance on 2001-08-16, under 510(k) number K010796.

Who is the listed applicant for AIA-PACK BRCA, ST AIA PACK BRCA?

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

What is the FDA product code for AIA-PACK BRCA, ST AIA PACK BRCA?

The FDA product code for AIA-PACK BRCA, ST AIA PACK BRCA is MOI.

Other records listing Tosoh Medics, Inc. as applicant

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Related Devices (Code: MOI)

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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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