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FDA 510(k)

ORION'S URINARY DRAINAGE SET

K-Number: K944377 · 1994-12-06

ApplicantRegulatory & Marketing Services, Inc.
Decision Date1994-12-06
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ORION'S URINARY DRAINAGE SET is the device name listed in this FDA 510(k) record. The listed applicant is Regulatory & Marketing Services, Inc.. It received FDA 510(k) clearance on 1994-12-06 under 510(k) number K944377. 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 ORION'S URINARY DRAINAGE SET?

ORION'S URINARY DRAINAGE SET is a medical device that received FDA 510(k) clearance on 1994-12-06. The listed applicant is Regulatory & Marketing Services, Inc.. The 510(k) number is K944377.

When did ORION'S URINARY DRAINAGE SET receive FDA 510(k) clearance?

ORION'S URINARY DRAINAGE SET received FDA 510(k) clearance on 1994-12-06, under 510(k) number K944377.

Who is the listed applicant for ORION'S URINARY DRAINAGE SET?

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

What is the FDA product code for ORION'S URINARY DRAINAGE SET?

The FDA product code for ORION'S URINARY DRAINAGE SET is KNX.

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Other records listing Regulatory & Marketing Services, 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.

K101721WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULAK944673MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBEK954752PEDIATRIC EUROPHYLIC FOLEY CATHETERK941342PAIN DOCK941543DIAL MEDICAL KITK944379ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG

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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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