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FDA 510(k)

EXTERNAL INCONTINENCE CATHETER TAKE-HOME

K-Number: K832109 · 1983-07-18

ApplicantPlasco, Inc.
Decision Date1983-07-18
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXTERNAL INCONTINENCE CATHETER TAKE-HOME is the device name listed in this FDA 510(k) record. The listed applicant is Plasco, Inc.. It received FDA 510(k) clearance on 1983-07-18 under 510(k) number K832109. 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 EXTERNAL INCONTINENCE CATHETER TAKE-HOME?

EXTERNAL INCONTINENCE CATHETER TAKE-HOME is a medical device that received FDA 510(k) clearance on 1983-07-18. The listed applicant is Plasco, Inc.. The 510(k) number is K832109.

When did EXTERNAL INCONTINENCE CATHETER TAKE-HOME receive FDA 510(k) clearance?

EXTERNAL INCONTINENCE CATHETER TAKE-HOME received FDA 510(k) clearance on 1983-07-18, under 510(k) number K832109.

Who is the listed applicant for EXTERNAL INCONTINENCE CATHETER TAKE-HOME?

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

What is the FDA product code for EXTERNAL INCONTINENCE CATHETER TAKE-HOME?

The FDA product code for EXTERNAL INCONTINENCE CATHETER TAKE-HOME is KNX.

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Other records listing Plasco, 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.

K980066CPR FILTERSHIELDK953414CPR MICROMASK WITH OXYGEN INLETK951483CPR MICROMASKK950770CPR MICROSHIELD IIK950769CPR MICROMASK PLUS CATALOG NO 73-402K943386CPR MICROMASK

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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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