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FDA 510(k)

H-H ALIMENTATION CATHETERS

K-Number: K821012 · 1982-05-28

ApplicantHolter-Hausner Intl.
Decision Date1982-05-28
Product CodeLFJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

H-H ALIMENTATION CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Holter-Hausner Intl.. It received FDA 510(k) clearance on 1982-05-28 under 510(k) number K821012. 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 H-H ALIMENTATION CATHETERS?

H-H ALIMENTATION CATHETERS is a medical device that received FDA 510(k) clearance on 1982-05-28. The listed applicant is Holter-Hausner Intl.. The 510(k) number is K821012.

When did H-H ALIMENTATION CATHETERS receive FDA 510(k) clearance?

H-H ALIMENTATION CATHETERS received FDA 510(k) clearance on 1982-05-28, under 510(k) number K821012.

Who is the listed applicant for H-H ALIMENTATION CATHETERS?

The FDA 510(k) record lists Holter-Hausner Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H-H ALIMENTATION CATHETERS?

The FDA product code for H-H ALIMENTATION CATHETERS is LFJ.

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Other records listing Holter-Hausner Intl. as applicant

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Related Devices (Code: LFJ)

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.

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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