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FDA 510(k)

AMSURE CLEANSING ENEMA SET

K-Number: K974042 · 1997-12-19

ApplicantAmsino Intl., Inc.
Decision Date1997-12-19
Product CodeFCE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMSURE CLEANSING ENEMA SET is the device name listed in this FDA 510(k) record. The listed applicant is Amsino Intl., Inc.. It received FDA 510(k) clearance on 1997-12-19 under 510(k) number K974042. 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 AMSURE CLEANSING ENEMA SET?

AMSURE CLEANSING ENEMA SET is a medical device that received FDA 510(k) clearance on 1997-12-19. The listed applicant is Amsino Intl., Inc.. The 510(k) number is K974042.

When did AMSURE CLEANSING ENEMA SET receive FDA 510(k) clearance?

AMSURE CLEANSING ENEMA SET received FDA 510(k) clearance on 1997-12-19, under 510(k) number K974042.

Who is the listed applicant for AMSURE CLEANSING ENEMA SET?

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

What is the FDA product code for AMSURE CLEANSING ENEMA SET?

The FDA product code for AMSURE CLEANSING ENEMA SET is FCE.

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Other records listing Amsino Intl., Inc. as applicant

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.

K070873AMSURE BLADDER IRRIGATION SETK992719AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKEK973107AMSINO I.V. ADMINISTRATION SETK973199AMSINO SUCTION CATHETERK971929AMSINO URINARY LEG BAGK964745AMSINO URINARY DRAINAGE BAG

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Related Devices (Code: FCE)

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.

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.K901179ENEMA BUCKET 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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