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FDA 510(k)

PRO-FLO SYSTEM

K-Number: K931896 · 1993-08-26

ApplicantLafayette Pharmacal, Inc.
Decision Date1993-08-26
Product CodeFCE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRO-FLO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lafayette Pharmacal, Inc.. It received FDA 510(k) clearance on 1993-08-26 under 510(k) number K931896. 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 PRO-FLO SYSTEM?

PRO-FLO SYSTEM is a medical device that received FDA 510(k) clearance on 1993-08-26. The listed applicant is Lafayette Pharmacal, Inc.. The 510(k) number is K931896.

When did PRO-FLO SYSTEM receive FDA 510(k) clearance?

PRO-FLO SYSTEM received FDA 510(k) clearance on 1993-08-26, under 510(k) number K931896.

Who is the listed applicant for PRO-FLO SYSTEM?

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

What is the FDA product code for PRO-FLO SYSTEM?

The FDA product code for PRO-FLO SYSTEM 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 Lafayette Pharmacal, 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.

K884379MAGLINTE ENTEROCLYSIS CATHETERK881609SITZMARKSK860441ENTROKIT WITH MAGLINTE CATHETER

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.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

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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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