FDA 510(k)

STERILE FLUID PRODUCING UNIT #EP550

K-Number: K832040 · 1983-09-29

ApplicantAmerican Cystocope Makers, Inc.

Decision Date1983-09-29

Product CodeLJH

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

STERILE FLUID PRODUCING UNIT #EP550 is the device name listed in this FDA 510(k) record. The listed applicant is American Cystocope Makers, Inc.. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K832040. The device is classified under product code LJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE FLUID PRODUCING UNIT #EP550?

STERILE FLUID PRODUCING UNIT #EP550 is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is American Cystocope Makers, Inc.. The 510(k) number is K832040.

When did STERILE FLUID PRODUCING UNIT #EP550 receive FDA 510(k) clearance?

STERILE FLUID PRODUCING UNIT #EP550 received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832040.

Who is the listed applicant for STERILE FLUID PRODUCING UNIT #EP550?

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

What is the FDA product code for STERILE FLUID PRODUCING UNIT #EP550?

The FDA product code for STERILE FLUID PRODUCING UNIT #EP550 is LJH.

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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.