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FDA 510(k)

IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD.

K-Number: K800603 · 1980-03-25

ApplicantTelectronics, Inc.
Decision Date1980-03-25
Product Code
DecisionSubstantially Equivalent

Device Summary

IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD. is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1980-03-25 under 510(k) number K800603. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD.?

IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD. is a medical device that received FDA 510(k) clearance on 1980-03-25. The listed applicant is Telectronics, Inc.. The 510(k) number is K800603.

When did IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD. receive FDA 510(k) clearance?

IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD. received FDA 510(k) clearance on 1980-03-25, under 510(k) number K800603.

Who is the listed applicant for IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD.?

The FDA 510(k) record lists Telectronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Telectronics, Inc. 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.

K890895IMPLANTABLE ADAPTOR 033-380K891231OPTIMA MPT AND SPT PACEMAKERSK890350VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)K884411OPTIMA MPT AND SPT PACEMAKERSK884278IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436K881837OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D

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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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