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FDA 510(k)

OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818

K-Number: K990509 · 1999-05-18

ApplicantImplemed, Inc.
Decision Date1999-05-18
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 is the device name listed in this FDA 510(k) record. The listed applicant is Implemed, Inc.. It received FDA 510(k) clearance on 1999-05-18 under 510(k) number K990509. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818?

OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 is a medical device that received FDA 510(k) clearance on 1999-05-18. The listed applicant is Implemed, Inc.. The 510(k) number is K990509.

When did OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 receive FDA 510(k) clearance?

OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 received FDA 510(k) clearance on 1999-05-18, under 510(k) number K990509.

Who is the listed applicant for OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818?

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

What is the FDA product code for OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818?

The FDA product code for OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 is EZL.

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Related Devices (Code: EZL)

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.

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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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