FDA 510(k)

FLUORESOFT

K-Number: K780125 · 1978-03-15

Decision Date1978-03-15

Product CodeKYC

DecisionSubstantially Equivalent

Device Summary

FLUORESOFT is the device name listed in this FDA 510(k) record. The listed applicant is Holles Laboratories, Inc.. It received FDA 510(k) clearance on 1978-03-15 under 510(k) number K780125. The device is classified under product code KYC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORESOFT?

FLUORESOFT is a medical device that received FDA 510(k) clearance on 1978-03-15. The listed applicant is Holles Laboratories, Inc.. The 510(k) number is K780125.

When did FLUORESOFT receive FDA 510(k) clearance?

FLUORESOFT received FDA 510(k) clearance on 1978-03-15, under 510(k) number K780125.

Who is the listed applicant for FLUORESOFT?

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

What is the FDA product code for FLUORESOFT?

The FDA product code for FLUORESOFT is KYC.

Related Clinical Trials

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Related Devices (Code: KYC)

K831621FLUORETS STERILE OPHTH. STRIPSSmith & Nephew, Inc.K810285BARNES-HIND ROSE BENGAL OPHTHALMIC STR.Barnes-Hind, 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.