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FDA 510(k)

COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA

K-Number: K822386 · 1982-10-06

ApplicantHospal Medical Corp.
Decision Date1982-10-06
Product CodeFII
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA is the device name listed in this FDA 510(k) record. The listed applicant is Hospal Medical Corp.. It received FDA 510(k) clearance on 1982-10-06 under 510(k) number K822386. The device is classified under product code FII. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA?

COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA is a medical device that received FDA 510(k) clearance on 1982-10-06. The listed applicant is Hospal Medical Corp.. The 510(k) number is K822386.

When did COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA receive FDA 510(k) clearance?

COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA received FDA 510(k) clearance on 1982-10-06, under 510(k) number K822386.

Who is the listed applicant for COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA?

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

What is the FDA product code for COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA?

The FDA product code for COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA is FII.

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Other records listing Hospal Medical Corp. as applicant

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Related Devices (Code: FII)

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.

K030470NXSTAGE SYSTEM ONENxstage Medical, Inc.K881270GAMBRO MULTIPURPOSE SYSTEM MPS-10Gambro, Inc.K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309Travenol Laboratories, S.A.K862716HEMOFILTRATION SYSTEM 10Gambro, 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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