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FDA 510(k)

RESTERILIZATION OF IMPLANTABLE ELECTRODE

K-Number: K800891 · 1980-05-28

ApplicantTelectronics, Inc.
Decision Date1980-05-28
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RESTERILIZATION OF IMPLANTABLE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K800891. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESTERILIZATION OF IMPLANTABLE ELECTRODE?

RESTERILIZATION OF IMPLANTABLE ELECTRODE is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Telectronics, Inc.. The 510(k) number is K800891.

When did RESTERILIZATION OF IMPLANTABLE ELECTRODE receive FDA 510(k) clearance?

RESTERILIZATION OF IMPLANTABLE ELECTRODE received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800891.

Who is the listed applicant for RESTERILIZATION OF IMPLANTABLE ELECTRODE?

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

What is the FDA product code for RESTERILIZATION OF IMPLANTABLE ELECTRODE?

The FDA product code for RESTERILIZATION OF IMPLANTABLE ELECTRODE is DTB.

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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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Related Devices (Code: DTB)

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.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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