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FDA 510(k)

PADGETT AIR DERMATOME, MODEL A

K-Number: K951085 · 1995-05-15

ApplicantPadgett Instruments, Inc.
Decision Date1995-05-15
Product CodeGFD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PADGETT AIR DERMATOME, MODEL A is the device name listed in this FDA 510(k) record. The listed applicant is Padgett Instruments, Inc.. It received FDA 510(k) clearance on 1995-05-15 under 510(k) number K951085. 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 PADGETT AIR DERMATOME, MODEL A?

PADGETT AIR DERMATOME, MODEL A is a medical device that received FDA 510(k) clearance on 1995-05-15. The listed applicant is Padgett Instruments, Inc.. The 510(k) number is K951085.

When did PADGETT AIR DERMATOME, MODEL A receive FDA 510(k) clearance?

PADGETT AIR DERMATOME, MODEL A received FDA 510(k) clearance on 1995-05-15, under 510(k) number K951085.

Who is the listed applicant for PADGETT AIR DERMATOME, MODEL A?

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

What is the FDA product code for PADGETT AIR DERMATOME, MODEL A?

The FDA product code for PADGETT AIR DERMATOME, MODEL A is GFD.

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Other records listing Padgett Instruments, 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.

K770970HAIR TRANSPLANT PUNCH, MULTIPLH

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 WorldwideK945594DECA DERMATOME (MICROMOTOR SYSTEM)Depuy Intl., Ltd.K940208AESCULAP ACCU-DERMATOMEAesculap, Inc.K862669ACTIVATED PARTIAL THROMBOPLASTIN TIME TESTU. S. Diagnostics, Inc.K861285SKIN MESH DEVICEPrecision Modified Devices

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.

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