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FDA 510(k)

PENLIGHT/SWAB HOLDER

K-Number: K791001 · 1979-06-22

ApplicantConcept, Inc.
Decision Date1979-06-22
Product CodeKYT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PENLIGHT/SWAB HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1979-06-22 under 510(k) number K791001. The device is classified under product code KYT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENLIGHT/SWAB HOLDER?

PENLIGHT/SWAB HOLDER is a medical device that received FDA 510(k) clearance on 1979-06-22. The listed applicant is Concept, Inc.. The 510(k) number is K791001.

When did PENLIGHT/SWAB HOLDER receive FDA 510(k) clearance?

PENLIGHT/SWAB HOLDER received FDA 510(k) clearance on 1979-06-22, under 510(k) number K791001.

Who is the listed applicant for PENLIGHT/SWAB HOLDER?

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 PENLIGHT/SWAB HOLDER?

The FDA product code for PENLIGHT/SWAB HOLDER is KYT.

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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: KYT)

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.

K920782OLYMPIC TRANS-LITEOlympic Medical Corp.K841589C-LITESuncoast Medical Manufacturers, Inc.K841588SUN-LITE WHITE SPOTSuncoast Medical Manufacturers, Inc.K781228PENLIGHTSAbco Dealers, Inc.K760972TYCOS DIAGNOSTIC PENLIGHTTaylor Instrument Analytics Co.

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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