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FDA 510(k)

IMPLANT SCIENCES CORP. MODEL HDR 4454

K-Number: K070468 · 2007-03-23

ApplicantImplant Sciences Corp.
Decision Date2007-03-23
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMPLANT SCIENCES CORP. MODEL HDR 4454 is the device name listed in this FDA 510(k) record. The listed applicant is Implant Sciences Corp.. It received FDA 510(k) clearance on 2007-03-23 under 510(k) number K070468. 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 IMPLANT SCIENCES CORP. MODEL HDR 4454?

IMPLANT SCIENCES CORP. MODEL HDR 4454 is a medical device that received FDA 510(k) clearance on 2007-03-23. The listed applicant is Implant Sciences Corp.. The 510(k) number is K070468.

When did IMPLANT SCIENCES CORP. MODEL HDR 4454 receive FDA 510(k) clearance?

IMPLANT SCIENCES CORP. MODEL HDR 4454 received FDA 510(k) clearance on 2007-03-23, under 510(k) number K070468.

Who is the listed applicant for IMPLANT SCIENCES CORP. MODEL HDR 4454?

The FDA 510(k) record lists Implant Sciences Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPLANT SCIENCES CORP. MODEL HDR 4454?

The FDA product code for IMPLANT SCIENCES CORP. MODEL HDR 4454 is KXK.

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.

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Other records listing Implant Sciences Corp. 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.

K042864IMPLANT SCIENCES CORP, MODEL HDR-4140K023073SEED LINKK023242I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILEK994317I-PLANT, MODEL 3500K990193IODINE BRACHYTHERAPY SEEDS, MODEL 3000

Related Devices (Code: KXK)

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.

K252296OncoPatchOncopatch, Inc.K242818IsoSphereIsoaid, LLCK223465RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc.K221539GammaTileGt Medical TechnologiesK202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation

Official Source

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