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FDA 510(k)

ENEMA KIT 'STRAIGHT' DESIGN

K-Number: K900848 · 1990-04-13

ApplicantCustom Medical Products, Ltd.
Decision Date1990-04-13
Product CodeFCE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENEMA KIT 'STRAIGHT' DESIGN is the device name listed in this FDA 510(k) record. The listed applicant is Custom Medical Products, Ltd.. It received FDA 510(k) clearance on 1990-04-13 under 510(k) number K900848. 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 KIT 'STRAIGHT' DESIGN?

ENEMA KIT 'STRAIGHT' DESIGN is a medical device that received FDA 510(k) clearance on 1990-04-13. The listed applicant is Custom Medical Products, Ltd.. The 510(k) number is K900848.

When did ENEMA KIT 'STRAIGHT' DESIGN receive FDA 510(k) clearance?

ENEMA KIT 'STRAIGHT' DESIGN received FDA 510(k) clearance on 1990-04-13, under 510(k) number K900848.

Who is the listed applicant for ENEMA KIT 'STRAIGHT' DESIGN?

The FDA 510(k) record lists Custom Medical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENEMA KIT 'STRAIGHT' DESIGN?

The FDA product code for ENEMA KIT 'STRAIGHT' DESIGN is FCE.

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Other records listing Custom Medical Products, Ltd. 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.

K931417STERILE EQUIPMENT COVERSK931456SURGICAL DRAPE AND GOWN TRAYK930815ABDOMINAL / THORACIC PATIENT DRAPEK931455HEAD SHEETK931418SURGICAL DRAPEK931844CUSTOM PROCEDURE MEDICAL TRAY OR KIT

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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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