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FDA 510(k)

CATHETER, EXTERNAL MALE NURSING CARE

K-Number: K781780 · 1978-12-07

ApplicantMedi-Tech, Inc.
Decision Date1978-12-07
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATHETER, EXTERNAL MALE NURSING CARE is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Tech, Inc.. It received FDA 510(k) clearance on 1978-12-07 under 510(k) number K781780. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER, EXTERNAL MALE NURSING CARE?

CATHETER, EXTERNAL MALE NURSING CARE is a medical device that received FDA 510(k) clearance on 1978-12-07. The listed applicant is Medi-Tech, Inc.. The 510(k) number is K781780.

When did CATHETER, EXTERNAL MALE NURSING CARE receive FDA 510(k) clearance?

CATHETER, EXTERNAL MALE NURSING CARE received FDA 510(k) clearance on 1978-12-07, under 510(k) number K781780.

Who is the listed applicant for CATHETER, EXTERNAL MALE NURSING CARE?

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

What is the FDA product code for CATHETER, EXTERNAL MALE NURSING CARE?

The FDA product code for CATHETER, EXTERNAL MALE NURSING CARE is KNX.

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Other records listing Medi-Tech, 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.

K954457MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETERK952345MEDI-TECH PLATFORM GUIDE CATHETERK952056IMMUNOASSAY DRUGS OF ABUSE CONTROLSK945289DOA - IMMUNOASSAY CUT-OFF CALIBRATORK942551THERAPEUTIC DRUG MONITORING CONTROL, ASSAYEDK943290BILIRUBIN PLUS/PEDIATRIC CONTROLS

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Related Devices (Code: KNX)

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.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, 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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