FDA 510(k)

DISPOSABLE & REUSABLE CHUCK HANDLE

K-Number: K945299 · 1994-11-09

Decision Date1994-11-09

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE & REUSABLE CHUCK HANDLE 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 1994-11-09 under 510(k) number K945299. 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 DISPOSABLE & REUSABLE CHUCK HANDLE?

DISPOSABLE & REUSABLE CHUCK HANDLE is a medical device that received FDA 510(k) clearance on 1994-11-09. The listed applicant is Boston Surgical Products, Inc.. The 510(k) number is K945299.

When did DISPOSABLE & REUSABLE CHUCK HANDLE receive FDA 510(k) clearance?

DISPOSABLE & REUSABLE CHUCK HANDLE received FDA 510(k) clearance on 1994-11-09, under 510(k) number K945299.

Who is the listed applicant for DISPOSABLE & REUSABLE CHUCK HANDLE?

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 DISPOSABLE & REUSABLE CHUCK HANDLE?

The FDA product code for DISPOSABLE & REUSABLE CHUCK HANDLE 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.