Ufr Fiberoptic Cable

FDA 510(k) K972225 · Universal Fiberoptic Repair, Inc.

Substantially Equivalent

510(k) numberK972225

Submission

Device name
Ufr Fiberoptic Cable
Applicant
Universal Fiberoptic Repair, Inc.
Pomfret Center, CT, US
Received
June 13, 1997
Decision date
March 18, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FST – Light, Surgical, Fiberoptic
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

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Questions and answers

When was Ufr Fiberoptic Cable cleared by the FDA?

Ufr Fiberoptic Cable (K972225) received a 510(k) decision of Substantially Equivalent on March 18, 1998, 278 days after the submission was received.

What is the product code of K972225?

The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.