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FDA 510(k)

FASTENS(TM)

K-Number: K854316 · 1986-02-28

ApplicantMedical Devices, Inc.
Decision Date1986-02-28
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FASTENS(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Devices, Inc.. It received FDA 510(k) clearance on 1986-02-28 under 510(k) number K854316. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASTENS(TM)?

FASTENS(TM) is a medical device that received FDA 510(k) clearance on 1986-02-28. The listed applicant is Medical Devices, Inc.. The 510(k) number is K854316.

When did FASTENS(TM) receive FDA 510(k) clearance?

FASTENS(TM) received FDA 510(k) clearance on 1986-02-28, under 510(k) number K854316.

Who is the listed applicant for FASTENS(TM)?

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

What is the FDA product code for FASTENS(TM)?

The FDA product code for FASTENS(TM) is GZJ.

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Other records listing Medical Devices, 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.

K002280PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602K930084MICRO-ARTHROSCOPEK943126ELECTROFLEXK940012SMARTBRACE ELECTRODEK935132HOME MICROCURRENT HMCK934619FLEXMATE

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Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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