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FDA 510(k)

NITINOL, NITI

K-Number: K935638 · 1994-05-18

ApplicantHighland Metals
Decision Date1994-05-18
Product CodeDZC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NITINOL, NITI is the device name listed in this FDA 510(k) record. The listed applicant is Highland Metals. It received FDA 510(k) clearance on 1994-05-18 under 510(k) number K935638. The device is classified under product code DZC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NITINOL, NITI?

NITINOL, NITI is a medical device that received FDA 510(k) clearance on 1994-05-18. The listed applicant is Highland Metals. The 510(k) number is K935638.

When did NITINOL, NITI receive FDA 510(k) clearance?

NITINOL, NITI received FDA 510(k) clearance on 1994-05-18, under 510(k) number K935638.

Who is the listed applicant for NITINOL, NITI?

The FDA 510(k) record lists Highland Metals as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITINOL, NITI?

The FDA product code for NITINOL, NITI is DZC.

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Other records listing Highland Metals 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.

K933374NITI COIL SPRINGSK933377STAINLESS STEEL ARCHES REPACKER RELABETERK933379STAINLESS STEEL ARCHESK933378REVERSE CURVE NITI ARCH WIRE REPACKER RELABETERK933376NITI ARCH WIRE ON A SPOOLK933380REVERSE SURVE NITI ARCH WIRE

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Related Devices (Code: DZC)

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.

K112640HYPERELASTIC WIREOrmco Corp.K943334HAWLEY RETAINER ORTHODONTIC APPLICANCE KITJay H. GellerK935140DENTAURUM STEEL LIGATURE WIRESDentauraum, Inc.K935142DENTAURUM WIRESDentauraum, Inc.K934265FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIREFlexmedicsK933374NITI COIL SPRINGSHighland Metals

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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