Far-East Barrier Gowns

FDA 510(k) K971702 · Far East Science & Technology Development Co., Ltd.

Substantially Equivalent

510(k) numberK971702

Submission

Device name
Far-East Barrier Gowns
Applicant
Far East Science & Technology Development Co., Ltd.
Garden Grove, CA, US
Received
May 8, 1997
Decision date
July 8, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FYC – Gown, Isolation, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4040
Specialty
General, Plastic Surgery

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More from Wuhan Dymex Healthcare Co., Ltd.

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Questions and answers

When was Far-East Barrier Gowns cleared by the FDA?

Far-East Barrier Gowns (K971702) received a 510(k) decision of Substantially Equivalent on July 8, 1997, 61 days after the submission was received.

What is the product code of K971702?

The FDA product code is FYC – Gown, Isolation, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.