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FDA 510(k)

AMPLIGREFFE

K-Number: K830993 · 1983-05-03

ApplicantProthia USA, Inc.
Decision Date1983-05-03
Product CodeGFD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMPLIGREFFE is the device name listed in this FDA 510(k) record. The listed applicant is Prothia USA, Inc.. It received FDA 510(k) clearance on 1983-05-03 under 510(k) number K830993. 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 AMPLIGREFFE?

AMPLIGREFFE is a medical device that received FDA 510(k) clearance on 1983-05-03. The listed applicant is Prothia USA, Inc.. The 510(k) number is K830993.

When did AMPLIGREFFE receive FDA 510(k) clearance?

AMPLIGREFFE received FDA 510(k) clearance on 1983-05-03, under 510(k) number K830993.

Who is the listed applicant for AMPLIGREFFE?

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

What is the FDA product code for AMPLIGREFFE?

The FDA product code for AMPLIGREFFE is GFD.

Related Clinical Trials

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.

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Other records listing Prothia USA, 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.

K831071UNIVERSAL INSTRU. SET FOR NEUROVASCULARK823581ELPHA 500K830058MYOGRAPH 2000K823583MYOTEST NERVE STIMULATOR

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.K951085PADGETT AIR DERMATOME, MODEL APadgett Instruments, Inc.K940208AESCULAP ACCU-DERMATOMEAesculap, Inc.K862669ACTIVATED PARTIAL THROMBOPLASTIN TIME TESTU. S. Diagnostics, Inc.

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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