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FDA 510(k)

CONCEPT CANALICULUS INTUBATION SET

K-Number: K802845 · 1980-12-17

ApplicantConcept, Inc.
Decision Date1980-12-17
Product CodeHNL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CONCEPT CANALICULUS INTUBATION 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 1980-12-17 under 510(k) number K802845. The device is classified under product code HNL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONCEPT CANALICULUS INTUBATION SET?

CONCEPT CANALICULUS INTUBATION SET is a medical device that received FDA 510(k) clearance on 1980-12-17. The listed applicant is Concept, Inc.. The 510(k) number is K802845.

When did CONCEPT CANALICULUS INTUBATION SET receive FDA 510(k) clearance?

CONCEPT CANALICULUS INTUBATION SET received FDA 510(k) clearance on 1980-12-17, under 510(k) number K802845.

Who is the listed applicant for CONCEPT CANALICULUS INTUBATION 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 CONCEPT CANALICULUS INTUBATION SET?

The FDA product code for CONCEPT CANALICULUS INTUBATION SET is HNL.

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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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Related Devices (Code: HNL)

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.

K843491CONCEPT FIBER OPTIC CANALICULUS INTUBAConcept, Inc.K840861TSE-ANDERSON MODIFIED LACRIMAL GROOVHansen Ophthalmic Development LabK833671STERILE OIL AND GUIDEWIRECooperVision, Inc.K831901LACIMAL INTUBATION SETSVisitec Co.K813187PILLING LACRIMAL INTUBATION SYSTEMNarco ScientificK812255ETHICON LACRIMAL STENTETHICON, 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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