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FDA 510(k)

MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700

K-Number: K880337 · 1988-04-14

ApplicantPlasco, Inc.
Decision Date1988-04-14
Product CodeFCE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 is the device name listed in this FDA 510(k) record. The listed applicant is Plasco, Inc.. It received FDA 510(k) clearance on 1988-04-14 under 510(k) number K880337. The device is classified under product code FCE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700?

MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 is a medical device that received FDA 510(k) clearance on 1988-04-14. The listed applicant is Plasco, Inc.. The 510(k) number is K880337.

When did MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 receive FDA 510(k) clearance?

MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 received FDA 510(k) clearance on 1988-04-14, under 510(k) number K880337.

Who is the listed applicant for MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700?

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

What is the FDA product code for MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700?

The FDA product code for MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 is FCE.

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Other records listing Plasco, Inc. as applicant

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Related Devices (Code: FCE)

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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.

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