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FDA 510(k)

JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT

K-Number: K925469 · 1995-05-03

ApplicantJ.J. Skinner, Inc.
Decision Date1995-05-03
Product CodeFKG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT is the device name listed in this FDA 510(k) record. The listed applicant is J.J. Skinner, Inc.. It received FDA 510(k) clearance on 1995-05-03 under 510(k) number K925469. The device is classified under product code FKG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT?

JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT is a medical device that received FDA 510(k) clearance on 1995-05-03. The listed applicant is J.J. Skinner, Inc.. The 510(k) number is K925469.

When did JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT receive FDA 510(k) clearance?

JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT received FDA 510(k) clearance on 1995-05-03, under 510(k) number K925469.

Who is the listed applicant for JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT?

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

What is the FDA product code for JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT?

The FDA product code for JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT is FKG.

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Other records listing J.J. Skinner, 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.

K961227JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAYK961683JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAYK925467JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KITK925468JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KITK903545CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITSK903544CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS

View all 7 devices →

Related Devices (Code: FKG)

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.

K871630KITS AND TRAYS FOR DIALYSIS USEDove Medical SuppliesK833780CAPD PREP KITProfessional Dialysis ProductsK802361DIALYIS START CARE KITMed-Pak Corp.K792207PERIDIAL PERITONEAL DIALYSIS TRAYCutter Laboratories, Inc.K790353ACUTE RENAL DIALYSIS TRAYArgon Medical Corp.

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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