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FDA 510(k)

CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR

K-Number: K903403 · 1990-10-01

ApplicantUniversity of Michigan
Decision Date1990-10-01
Product CodeIWJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is University of Michigan. It received FDA 510(k) clearance on 1990-10-01 under 510(k) number K903403. 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 CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR?

CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR is a medical device that received FDA 510(k) clearance on 1990-10-01. The listed applicant is University of Michigan. The 510(k) number is K903403.

When did CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR receive FDA 510(k) clearance?

CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR received FDA 510(k) clearance on 1990-10-01, under 510(k) number K903403.

Who is the listed applicant for CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR?

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

What is the FDA product code for CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR?

The FDA product code for CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR is IWJ.

Related Clinical Trials

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Other records listing University of Michigan 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.

K964968MR EXTENSION SET (001)

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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