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FDA 510(k)

SURGICAL ISOLATION BARRIER SYSTEM

K-Number: K831531 · 1984-06-05

ApplicantLone Star Medical Products, Inc.
Decision Date1984-06-05
Product Code
DecisionSubstantially Equivalent

Device Summary

SURGICAL ISOLATION BARRIER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lone Star Medical Products, Inc.. It received FDA 510(k) clearance on 1984-06-05 under 510(k) number K831531. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL ISOLATION BARRIER SYSTEM?

SURGICAL ISOLATION BARRIER SYSTEM is a medical device that received FDA 510(k) clearance on 1984-06-05. The listed applicant is Lone Star Medical Products, Inc.. The 510(k) number is K831531.

When did SURGICAL ISOLATION BARRIER SYSTEM receive FDA 510(k) clearance?

SURGICAL ISOLATION BARRIER SYSTEM received FDA 510(k) clearance on 1984-06-05, under 510(k) number K831531.

Who is the listed applicant for SURGICAL ISOLATION BARRIER SYSTEM?

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

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Other records listing Lone Star Medical Products, 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.

K850041P-3 CLOSING INSTRUMENTK820015URETHAL CUTTER CLAMPK810915THE SCOTT DIALMENZENSERTK802983THE INQUINAL RESORVOIR INSERTERK791665SCOTTS SURGICAL RETRACTOR AND ELASTIC

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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