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FDA 510(k)

PRECISION HARVEST & INLAY INSTRUMENT SET

K-Number: K851339 · 1985-07-02

ApplicantConcept, Inc.
Decision Date1985-07-02
Product CodeHWK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRECISION HARVEST & INLAY INSTRUMENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1985-07-02 under 510(k) number K851339. The device is classified under product code HWK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISION HARVEST & INLAY INSTRUMENT SET?

PRECISION HARVEST & INLAY INSTRUMENT SET is a medical device that received FDA 510(k) clearance on 1985-07-02. The listed applicant is Concept, Inc.. The 510(k) number is K851339.

When did PRECISION HARVEST & INLAY INSTRUMENT SET receive FDA 510(k) clearance?

PRECISION HARVEST & INLAY INSTRUMENT SET received FDA 510(k) clearance on 1985-07-02, under 510(k) number K851339.

Who is the listed applicant for PRECISION HARVEST & INLAY INSTRUMENT SET?

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

What is the FDA product code for PRECISION HARVEST & INLAY INSTRUMENT SET?

The FDA product code for PRECISION HARVEST & INLAY INSTRUMENT SET is HWK.

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Other records listing Concept, 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.

K912640CONCEPT ENDOSTEAL FIXATION DEVICEK912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

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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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