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FDA 510(k)

CIDEX*DIALYZER DISINFECTING SOLUTION

K-Number: K822535 · 1982-09-30

ApplicantSurgikos, Inc.
Decision Date1982-09-30
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CIDEX*DIALYZER DISINFECTING SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1982-09-30 under 510(k) number K822535. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIDEX*DIALYZER DISINFECTING SOLUTION?

CIDEX*DIALYZER DISINFECTING SOLUTION is a medical device that received FDA 510(k) clearance on 1982-09-30. The listed applicant is Surgikos, Inc.. The 510(k) number is K822535.

When did CIDEX*DIALYZER DISINFECTING SOLUTION receive FDA 510(k) clearance?

CIDEX*DIALYZER DISINFECTING SOLUTION received FDA 510(k) clearance on 1982-09-30, under 510(k) number K822535.

Who is the listed applicant for CIDEX*DIALYZER DISINFECTING SOLUTION?

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

What is the FDA product code for CIDEX*DIALYZER DISINFECTING SOLUTION?

The FDA product code for CIDEX*DIALYZER DISINFECTING SOLUTION is FKQ.

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Other records listing Surgikos, 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.

K875107HEALTH CARE EYE PROTECTIONK874653STERILE SURGICAL SCRUB BRUSHK861441NEUTRALON SURGICAL GLOVESK852870BARRIER SURGICAL GOWNK820543BARRIER ANTIMICROBIAL INCISE DRAPEK820542SURGIKOS INCISE DRAPE

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Related Devices (Code: FKQ)

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.

K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbHK893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.K873421KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific IndustriesK861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, 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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