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FDA 510(k)

PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL

K-Number: K850207 · 1985-03-01

ApplicantSyncor Intl. Corp.
Decision Date1985-03-01
Product Code
DecisionSubstantially Equivalent

Device Summary

PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL is the device name listed in this FDA 510(k) record. The listed applicant is Syncor Intl. Corp.. It received FDA 510(k) clearance on 1985-03-01 under 510(k) number K850207. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL?

PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL is a medical device that received FDA 510(k) clearance on 1985-03-01. The listed applicant is Syncor Intl. Corp.. The 510(k) number is K850207.

When did PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL receive FDA 510(k) clearance?

PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL received FDA 510(k) clearance on 1985-03-01, under 510(k) number K850207.

Who is the listed applicant for PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL?

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

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Other records listing Syncor Intl. 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.

K945825SECURE SAFETY INSERTK851828IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-CK850433CESIUM 137 ENDOMETRIAL SOURCEK852023CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41K852665SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAYK851033SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT

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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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