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FDA 510(k)

MCSCP8PS WITH 'Y' HUB

K-Number: K821684 · 1982-06-24

ApplicantMedical Components, Inc.
Decision Date1982-06-24
Product CodeLFJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MCSCP8PS WITH 'Y' HUB is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 1982-06-24 under 510(k) number K821684. The device is classified under product code LFJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCSCP8PS WITH 'Y' HUB?

MCSCP8PS WITH 'Y' HUB is a medical device that received FDA 510(k) clearance on 1982-06-24. The listed applicant is Medical Components, Inc.. The 510(k) number is K821684.

When did MCSCP8PS WITH 'Y' HUB receive FDA 510(k) clearance?

MCSCP8PS WITH 'Y' HUB received FDA 510(k) clearance on 1982-06-24, under 510(k) number K821684.

Who is the listed applicant for MCSCP8PS WITH 'Y' HUB?

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

What is the FDA product code for MCSCP8PS WITH 'Y' HUB?

The FDA product code for MCSCP8PS WITH 'Y' HUB is LFJ.

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Related Devices (Code: LFJ)

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K920780MEDSURG INSERTION TRAYMedsurg Industries, Inc.K925819AKCESS0CATH KITAkcess Medical Products, Inc.K925818AKCESS-CATHAkcess Medical Products, Inc.K913468ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAYCook, Inc.K931120COAXIAL ACUTE CATHETERAkcess Medical Products, Inc.K920634SPLITTABLE SHEATH INTRODUCER SETAkcess Medical Products, 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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