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FDA 510(k)

BERNSCO ELECTROSURGICAL SHIELD

K-Number: K883823 · 1988-10-04

Decision Date1988-10-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BERNSCO ELECTROSURGICAL SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Bernsco Surgical Supply, Inc.. It received FDA 510(k) clearance on 1988-10-04 under 510(k) number K883823. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BERNSCO ELECTROSURGICAL SHIELD?

BERNSCO ELECTROSURGICAL SHIELD is a medical device that received FDA 510(k) clearance on 1988-10-04. The listed applicant is Bernsco Surgical Supply, Inc.. The 510(k) number is K883823.

When did BERNSCO ELECTROSURGICAL SHIELD receive FDA 510(k) clearance?

BERNSCO ELECTROSURGICAL SHIELD received FDA 510(k) clearance on 1988-10-04, under 510(k) number K883823.

Who is the listed applicant for BERNSCO ELECTROSURGICAL SHIELD?

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

What is the FDA product code for BERNSCO ELECTROSURGICAL SHIELD?

The FDA product code for BERNSCO ELECTROSURGICAL SHIELD is GEI.

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 Bernsco Surgical Supply, 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: GEI)

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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