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FDA 510(k)

ERIKA EXTENSION SETS

K-Number: K810823 · 1981-04-17

ApplicantErika, Inc.
Decision Date1981-04-17
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ERIKA EXTENSION SETS is the device name listed in this FDA 510(k) record. The listed applicant is Erika, Inc.. It received FDA 510(k) clearance on 1981-04-17 under 510(k) number K810823. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERIKA EXTENSION SETS?

ERIKA EXTENSION SETS is a medical device that received FDA 510(k) clearance on 1981-04-17. The listed applicant is Erika, Inc.. The 510(k) number is K810823.

When did ERIKA EXTENSION SETS receive FDA 510(k) clearance?

ERIKA EXTENSION SETS received FDA 510(k) clearance on 1981-04-17, under 510(k) number K810823.

Who is the listed applicant for ERIKA EXTENSION SETS?

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

What is the FDA product code for ERIKA EXTENSION SETS?

The FDA product code for ERIKA EXTENSION SETS is FJK.

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Other records listing Erika, 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.

K853134NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8K852309ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1K852310NATURALYTE BICARBONATE CONCENTRATE-DRY PACKK850865TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-K850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1LK850654TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID

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Related Devices (Code: FJK)

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.

K252423NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd.K251341VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd.K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.K243607Moda-flx Hemodialysis System™ Cartridge (102121-001 )Diality, Inc.K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCK210782Tablo CartridgeOutset Medical, 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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