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FDA 510(k)

ENEMA SET

K-Number: K771792 · 1977-10-20

ApplicantChase Mfg. Co.
Decision Date1977-10-20
Product CodeFCE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENEMA SET is the device name listed in this FDA 510(k) record. The listed applicant is Chase Mfg. Co.. It received FDA 510(k) clearance on 1977-10-20 under 510(k) number K771792. 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 ENEMA SET?

ENEMA SET is a medical device that received FDA 510(k) clearance on 1977-10-20. The listed applicant is Chase Mfg. Co.. The 510(k) number is K771792.

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

ENEMA SET received FDA 510(k) clearance on 1977-10-20, under 510(k) number K771792.

Who is the listed applicant for ENEMA SET?

The FDA 510(k) record lists Chase Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENEMA SET?

The FDA product code for ENEMA SET is FCE.

Related Clinical Trials

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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Other records listing Chase Mfg. Co. 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.

K791513ADAMCO DUST COVERK790993INSTANT HOT & COLD PACKSK790644SUBMAXK780033MATTRESSES, CONDUCTIVE & COVERSK771791NEEDLE COUNTINGK770900CAST BRWM, FRACTURE

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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.

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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