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FDA 510(k)

COOK COUNTY HOSPITAL DRESSING CHANGE SET

K-Number: K843206 · 1985-05-24

ApplicantGeneva Laboratories, Inc.
Decision Date1985-05-24
Product CodeKDD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOK COUNTY HOSPITAL DRESSING CHANGE SET is the device name listed in this FDA 510(k) record. The listed applicant is Geneva Laboratories, Inc.. It received FDA 510(k) clearance on 1985-05-24 under 510(k) number K843206. The device is classified under product code KDD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK COUNTY HOSPITAL DRESSING CHANGE SET?

COOK COUNTY HOSPITAL DRESSING CHANGE SET is a medical device that received FDA 510(k) clearance on 1985-05-24. The listed applicant is Geneva Laboratories, Inc.. The 510(k) number is K843206.

When did COOK COUNTY HOSPITAL DRESSING CHANGE SET receive FDA 510(k) clearance?

COOK COUNTY HOSPITAL DRESSING CHANGE SET received FDA 510(k) clearance on 1985-05-24, under 510(k) number K843206.

Who is the listed applicant for COOK COUNTY HOSPITAL DRESSING CHANGE SET?

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

What is the FDA product code for COOK COUNTY HOSPITAL DRESSING CHANGE SET?

The FDA product code for COOK COUNTY HOSPITAL DRESSING CHANGE SET is KDD.

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Other records listing Geneva Laboratories, Inc. as applicant

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K881217GENT-L-KARE STERILE URINARY LEG BAGK881213GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTERK881218GENT-L-KARE CLEANSING ENEMA SETK881216GENT-L-KARE VAGINAL IRRIGATION SETK861308ACCUPAC CUSTOM PACK KERLIX SQUARESK861219ACCUPAC CUSTOM SKIN SCRUB KIT

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Related Devices (Code: KDD)

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.

K072814CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURESCovidienK011514INSTRUMENTS FOR ONE TIME USE - DISPOSABLEKencap , Ltd.K971317NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYSNational Healthcare Mfg. Corp.K960456DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAYDenver Biomaterials, Inc.K936255CUSTOM CV PACKAssociated MedicalK932219SUTURE SET OR LACERATION TRAYS (PACKS)Associated Medical Products Co.

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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