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FDA 510(k)

DECA DERMATOME (MICROMOTOR SYSTEM)

K-Number: K945594 · 1995-06-05

ApplicantDepuy Intl., Ltd.
Decision Date1995-06-05
Product CodeGFD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DECA DERMATOME (MICROMOTOR SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Intl., Ltd.. It received FDA 510(k) clearance on 1995-06-05 under 510(k) number K945594. The device is classified under product code GFD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DECA DERMATOME (MICROMOTOR SYSTEM)?

DECA DERMATOME (MICROMOTOR SYSTEM) is a medical device that received FDA 510(k) clearance on 1995-06-05. The listed applicant is Depuy Intl., Ltd.. The 510(k) number is K945594.

When did DECA DERMATOME (MICROMOTOR SYSTEM) receive FDA 510(k) clearance?

DECA DERMATOME (MICROMOTOR SYSTEM) received FDA 510(k) clearance on 1995-06-05, under 510(k) number K945594.

Who is the listed applicant for DECA DERMATOME (MICROMOTOR SYSTEM)?

The FDA 510(k) record lists Depuy Intl., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DECA DERMATOME (MICROMOTOR SYSTEM)?

The FDA product code for DECA DERMATOME (MICROMOTOR SYSTEM) is GFD.

Related Clinical Trials

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Related Devices (Code: GFD)

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.

K965256DMS-1000C DERMOABRADERMattioli Engineering, SrlK962371DERMTOME BLADEDsp WorldwideK951085PADGETT AIR DERMATOME, MODEL APadgett Instruments, Inc.K940208AESCULAP ACCU-DERMATOMEAesculap, Inc.K862669ACTIVATED PARTIAL THROMBOPLASTIN TIME TESTU. S. Diagnostics, Inc.K861285SKIN MESH DEVICEPrecision Modified Devices

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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