FDA 510(k)

BIOPLAR CORD -DISPOSABLE 30-1538

K-Number: K833015 · 1983-10-14

Decision Date1983-10-14

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BIOPLAR CORD -DISPOSABLE 30-1538 is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K833015. 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 BIOPLAR CORD -DISPOSABLE 30-1538?

BIOPLAR CORD -DISPOSABLE 30-1538 is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K833015.

When did BIOPLAR CORD -DISPOSABLE 30-1538 receive FDA 510(k) clearance?

BIOPLAR CORD -DISPOSABLE 30-1538 received FDA 510(k) clearance on 1983-10-14, under 510(k) number K833015.

Who is the listed applicant for BIOPLAR CORD -DISPOSABLE 30-1538?

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

What is the FDA product code for BIOPLAR CORD -DISPOSABLE 30-1538?

The FDA product code for BIOPLAR CORD -DISPOSABLE 30-1538 is GEI.

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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.