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FDA 510(k)

ATT-300

K-Number: K944699 · 1995-05-26

Decision Date1995-05-26
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ATT-300 is the device name listed in this FDA 510(k) record. The listed applicant is Health Care Mfg., Inc.. It received FDA 510(k) clearance on 1995-05-26 under 510(k) number K944699. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATT-300?

ATT-300 is a medical device that received FDA 510(k) clearance on 1995-05-26. The listed applicant is Health Care Mfg., Inc.. The 510(k) number is K944699.

When did ATT-300 receive FDA 510(k) clearance?

ATT-300 received FDA 510(k) clearance on 1995-05-26, under 510(k) number K944699.

Who is the listed applicant for ATT-300?

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

What is the FDA product code for ATT-300?

The FDA product code for ATT-300 is ITH.

Other records listing Health Care Mfg., Inc. as applicant

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.

View all 7 devices →

Related Devices (Code: ITH)

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

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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