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FDA 510(k)

QUADRIPLEGIC URINARY DRAINAGE VALVE

K-Number: K772402 · 1978-01-26

ApplicantFred Sammons, Inc.
Decision Date1978-01-26
Product CodeFAQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

QUADRIPLEGIC URINARY DRAINAGE VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Fred Sammons, Inc.. It received FDA 510(k) clearance on 1978-01-26 under 510(k) number K772402. The device is classified under product code FAQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUADRIPLEGIC URINARY DRAINAGE VALVE?

QUADRIPLEGIC URINARY DRAINAGE VALVE is a medical device that received FDA 510(k) clearance on 1978-01-26. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K772402.

When did QUADRIPLEGIC URINARY DRAINAGE VALVE receive FDA 510(k) clearance?

QUADRIPLEGIC URINARY DRAINAGE VALVE received FDA 510(k) clearance on 1978-01-26, under 510(k) number K772402.

Who is the listed applicant for QUADRIPLEGIC URINARY DRAINAGE VALVE?

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

What is the FDA product code for QUADRIPLEGIC URINARY DRAINAGE VALVE?

The FDA product code for QUADRIPLEGIC URINARY DRAINAGE VALVE is FAQ.

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Other records listing Fred Sammons, Inc. as applicant

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Related Devices (Code: FAQ)

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.

K962604PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZINGConvatec, A Division of E.R. Squibb & SonsK960217CPR URINE BAGCustom Pack ReliabilityK955609CONVEEN URINE BAG - STERILEColoplast Corp.K953767PROSYS BEDSIDE DRAINAGE BAGConvatec, A Division of E.R. Squibb & SonsK953783CONVEEN LEG BAG STRAPColoplast Corp.K951945PROSYS LEG BAGConvatec, A Division of E.R. Squibb & Sons

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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