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FDA 510(k)

WEEKS APPLICATOR

K-Number: K951052 · 1996-08-22

ApplicantDuke University Medical Center
Decision Date1996-08-22
Product CodeIWJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

WEEKS APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Duke University Medical Center. It received FDA 510(k) clearance on 1996-08-22 under 510(k) number K951052. The device is classified under product code IWJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WEEKS APPLICATOR?

WEEKS APPLICATOR is a medical device that received FDA 510(k) clearance on 1996-08-22. The listed applicant is Duke University Medical Center. The 510(k) number is K951052.

When did WEEKS APPLICATOR receive FDA 510(k) clearance?

WEEKS APPLICATOR received FDA 510(k) clearance on 1996-08-22, under 510(k) number K951052.

Who is the listed applicant for WEEKS APPLICATOR?

The FDA 510(k) record lists Duke University Medical Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WEEKS APPLICATOR?

The FDA product code for WEEKS APPLICATOR is IWJ.

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Related Devices (Code: IWJ)

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.

K010166IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEMImagyn Medical Technologies, Inc.K980997PGK DEVICE (MODIFIED)Pgk, Inc.K972554REGANES RADIONUCLIDE SEED MAGAZINEAvid N.I.T., Inc.K973037N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000Avid N.I.T., Inc.K974118WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SETWorldwide Medical Technologies, LLCK973786NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDENw Radiation Therapy Products

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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