FDA 510(k)

CUTTER RESIFLEX FOLEY CATHETERS

K-Number: K781140 · 1978-09-07

Decision Date1978-09-07

Product CodeDJC

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

CUTTER RESIFLEX FOLEY CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Cutler Laboratories, Inc.. It received FDA 510(k) clearance on 1978-09-07 under 510(k) number K781140. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUTTER RESIFLEX FOLEY CATHETERS?

CUTTER RESIFLEX FOLEY CATHETERS is a medical device that received FDA 510(k) clearance on 1978-09-07. The listed applicant is Cutler Laboratories, Inc.. The 510(k) number is K781140.

When did CUTTER RESIFLEX FOLEY CATHETERS receive FDA 510(k) clearance?

CUTTER RESIFLEX FOLEY CATHETERS received FDA 510(k) clearance on 1978-09-07, under 510(k) number K781140.

Who is the listed applicant for CUTTER RESIFLEX FOLEY CATHETERS?

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

What is the FDA product code for CUTTER RESIFLEX FOLEY CATHETERS?

The FDA product code for CUTTER RESIFLEX FOLEY CATHETERS is DJC.

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Related Devices (Code: DJC)

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.