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FDA 510(k)

HOLLISTER FEMALE URINARY COLLECT SYS

K-Number: K820234 · 1982-02-10

ApplicantHollister, Inc.
Decision Date1982-02-10
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOLLISTER FEMALE URINARY COLLECT SYS is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1982-02-10 under 510(k) number K820234. 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 HOLLISTER FEMALE URINARY COLLECT SYS?

HOLLISTER FEMALE URINARY COLLECT SYS is a medical device that received FDA 510(k) clearance on 1982-02-10. The listed applicant is Hollister, Inc.. The 510(k) number is K820234.

When did HOLLISTER FEMALE URINARY COLLECT SYS receive FDA 510(k) clearance?

HOLLISTER FEMALE URINARY COLLECT SYS received FDA 510(k) clearance on 1982-02-10, under 510(k) number K820234.

Who is the listed applicant for HOLLISTER FEMALE URINARY COLLECT SYS?

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

What is the FDA product code for HOLLISTER FEMALE URINARY COLLECT SYS?

The FDA product code for HOLLISTER FEMALE URINARY COLLECT SYS is KNX.

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Other records listing Hollister, Inc. as applicant

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K123804INSTAFLO BOWEL CATHETER SYSTEM KITK100273INSTAFLO BOWEL CATHETER SYSTEM KITK090960VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,K083153ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007K050483EVADRI BLADDER CONTROL SYSTEMSK040779RESTORE WOUND CLEANSER

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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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