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FDA 510(k)

H-H SEXTON SCUP URINE MGMT. SYS

K-Number: K853458 · 1985-08-27

ApplicantHolter-Hausner Intl.
Decision Date1985-08-27
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

H-H SEXTON SCUP URINE MGMT. SYS is the device name listed in this FDA 510(k) record. The listed applicant is Holter-Hausner Intl.. It received FDA 510(k) clearance on 1985-08-27 under 510(k) number K853458. 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 H-H SEXTON SCUP URINE MGMT. SYS?

H-H SEXTON SCUP URINE MGMT. SYS is a medical device that received FDA 510(k) clearance on 1985-08-27. The listed applicant is Holter-Hausner Intl.. The 510(k) number is K853458.

When did H-H SEXTON SCUP URINE MGMT. SYS receive FDA 510(k) clearance?

H-H SEXTON SCUP URINE MGMT. SYS received FDA 510(k) clearance on 1985-08-27, under 510(k) number K853458.

Who is the listed applicant for H-H SEXTON SCUP URINE MGMT. SYS?

The FDA 510(k) record lists Holter-Hausner Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H-H SEXTON SCUP URINE MGMT. SYS?

The FDA product code for H-H SEXTON SCUP URINE MGMT. SYS is KNX.

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Other records listing Holter-Hausner Intl. as applicant

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K875287H-H FLUSHING RESERVOIRK874508H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAGK872293H-H HUNTER ACTIVE TENDON IMPLANT BCK872285H-H HUNTER ACTIVE TENDON IMPLANT DCK872284H-H HUNTER ACTIVE TENDON IMPLANT PCK871351H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP

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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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