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FDA 510(k)

SPS SUSPENSION ENEMA KIT

K-Number: K872992 · 1987-09-17

ApplicantCarolina Medical Products Co.
Decision Date1987-09-17
Product CodeFCE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPS SUSPENSION ENEMA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Medical Products Co.. It received FDA 510(k) clearance on 1987-09-17 under 510(k) number K872992. 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 SPS SUSPENSION ENEMA KIT?

SPS SUSPENSION ENEMA KIT is a medical device that received FDA 510(k) clearance on 1987-09-17. The listed applicant is Carolina Medical Products Co.. The 510(k) number is K872992.

When did SPS SUSPENSION ENEMA KIT receive FDA 510(k) clearance?

SPS SUSPENSION ENEMA KIT received FDA 510(k) clearance on 1987-09-17, under 510(k) number K872992.

Who is the listed applicant for SPS SUSPENSION ENEMA KIT?

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

What is the FDA product code for SPS SUSPENSION ENEMA KIT?

The FDA product code for SPS SUSPENSION ENEMA KIT is FCE.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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