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FDA 510(k)

STERILE PACKAGED POWER INSTRUMENT ACCESSORIES

K-Number: K911930 · 1991-07-02

ApplicantUnited American Medical Co., Inc.
Decision Date1991-07-02
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE PACKAGED POWER INSTRUMENT ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is United American Medical Co., Inc.. It received FDA 510(k) clearance on 1991-07-02 under 510(k) number K911930. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE PACKAGED POWER INSTRUMENT ACCESSORIES?

STERILE PACKAGED POWER INSTRUMENT ACCESSORIES is a medical device that received FDA 510(k) clearance on 1991-07-02. The listed applicant is United American Medical Co., Inc.. The 510(k) number is K911930.

When did STERILE PACKAGED POWER INSTRUMENT ACCESSORIES receive FDA 510(k) clearance?

STERILE PACKAGED POWER INSTRUMENT ACCESSORIES received FDA 510(k) clearance on 1991-07-02, under 510(k) number K911930.

Who is the listed applicant for STERILE PACKAGED POWER INSTRUMENT ACCESSORIES?

The FDA 510(k) record lists United American Medical Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE PACKAGED POWER INSTRUMENT ACCESSORIES?

The FDA product code for STERILE PACKAGED POWER INSTRUMENT ACCESSORIES is HWE.

Related Clinical Trials

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Other records listing United American Medical Co., 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.

K930319OSTEON ADAPTOR/CRADLEK911929SMALL BONE FIXATION SYSTEM

Related Devices (Code: HWE)

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.

K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions LimitedK063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEThe Anspach Effort, Inc.K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMZimmer TrabecularK043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSMedical Device ServicesK012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSAdven Medical

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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