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FDA 510(k)

PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE

K-Number: K890072 · 1989-06-12

ApplicantMedireach, Inc.
Decision Date1989-06-12
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE is the device name listed in this FDA 510(k) record. The listed applicant is Medireach, Inc.. It received FDA 510(k) clearance on 1989-06-12 under 510(k) number K890072. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE?

PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE is a medical device that received FDA 510(k) clearance on 1989-06-12. The listed applicant is Medireach, Inc.. The 510(k) number is K890072.

When did PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE receive FDA 510(k) clearance?

PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE received FDA 510(k) clearance on 1989-06-12, under 510(k) number K890072.

Who is the listed applicant for PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE?

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

What is the FDA product code for PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE?

The FDA product code for PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE is KNY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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