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FDA 510(k)

NORTHEAST PROTON THERAPY CENTER

K-Number: K983332 · 2001-07-20

ApplicantMassachusetts General Hospital
Decision Date2001-07-20
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NORTHEAST PROTON THERAPY CENTER is the device name listed in this FDA 510(k) record. The listed applicant is Massachusetts General Hospital. It received FDA 510(k) clearance on 2001-07-20 under 510(k) number K983332. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTHEAST PROTON THERAPY CENTER?

NORTHEAST PROTON THERAPY CENTER is a medical device that received FDA 510(k) clearance on 2001-07-20. The listed applicant is Massachusetts General Hospital. The 510(k) number is K983332.

When did NORTHEAST PROTON THERAPY CENTER receive FDA 510(k) clearance?

NORTHEAST PROTON THERAPY CENTER received FDA 510(k) clearance on 2001-07-20, under 510(k) number K983332.

Who is the listed applicant for NORTHEAST PROTON THERAPY CENTER?

The FDA 510(k) record lists Massachusetts General Hospital as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORTHEAST PROTON THERAPY CENTER?

The FDA product code for NORTHEAST PROTON THERAPY CENTER is LHN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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