FDA 510(k)

DISOPOSABLE & RESUABLE MONPOLAR CORD

K-Number: K951912 · 1995-05-12

Decision Date1995-05-12

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DISOPOSABLE & RESUABLE MONPOLAR CORD is the device name listed in this FDA 510(k) record. The listed applicant is Boston Surgical Products, Inc.. It received FDA 510(k) clearance on 1995-05-12 under 510(k) number K951912. 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 DISOPOSABLE & RESUABLE MONPOLAR CORD?

DISOPOSABLE & RESUABLE MONPOLAR CORD is a medical device that received FDA 510(k) clearance on 1995-05-12. The listed applicant is Boston Surgical Products, Inc.. The 510(k) number is K951912.

When did DISOPOSABLE & RESUABLE MONPOLAR CORD receive FDA 510(k) clearance?

DISOPOSABLE & RESUABLE MONPOLAR CORD received FDA 510(k) clearance on 1995-05-12, under 510(k) number K951912.

Who is the listed applicant for DISOPOSABLE & RESUABLE MONPOLAR CORD?

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

What is the FDA product code for DISOPOSABLE & RESUABLE MONPOLAR CORD?

The FDA product code for DISOPOSABLE & RESUABLE MONPOLAR CORD is GEI.

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Other records listing Boston Surgical Products, Inc. as applicant

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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.