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FDA 510(k)

BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM

K-Number: K911518 · 1992-11-09

Decision Date1992-11-09
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM is the device name listed in this FDA 510(k) record. The listed applicant is Lead-Lok, Inc.. It received FDA 510(k) clearance on 1992-11-09 under 510(k) number K911518. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM?

BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM is a medical device that received FDA 510(k) clearance on 1992-11-09. The listed applicant is Lead-Lok, Inc.. The 510(k) number is K911518.

When did BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM receive FDA 510(k) clearance?

BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM received FDA 510(k) clearance on 1992-11-09, under 510(k) number K911518.

Who is the listed applicant for BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM?

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

What is the FDA product code for BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM?

The FDA product code for BUNNY ELECTRODE/STEALTH SOLID GEL-SNAP ON FOAM is DRX.

Related Clinical Trials

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.

Other records listing Lead-Lok, 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.

Related Devices (Code: DRX)

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.

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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