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FDA 510(k)

MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY

K-Number: K870796 · 1987-04-01

ApplicantPlasco, Inc.
Decision Date1987-04-01
Product CodeFCE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY is the device name listed in this FDA 510(k) record. The listed applicant is Plasco, Inc.. It received FDA 510(k) clearance on 1987-04-01 under 510(k) number K870796. 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-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY?

MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY is a medical device that received FDA 510(k) clearance on 1987-04-01. The listed applicant is Plasco, Inc.. The 510(k) number is K870796.

When did MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY receive FDA 510(k) clearance?

MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY received FDA 510(k) clearance on 1987-04-01, under 510(k) number K870796.

Who is the listed applicant for MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY?

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-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY?

The FDA product code for MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY 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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K974042AMSURE CLEANSING ENEMA SETAmsino Intl., Inc.K931896PRO-FLO SYSTEMLafayette Pharmacal, Inc.K9223984 SURE TM ENEMA BAG SETBoston Pacific Medical, Inc.K913620ENEMA KITYork County Blind CenterK904534ENEMA BULBR.A.C., Inc.K901182ENEMA BAG SETOrion Life Systems, 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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