Aqua Spray

FDA 510(k) K971941 · Boyd Industries, Inc.

Substantially Equivalent

510(k) numberK971941

Submission

Device name
Aqua Spray
Applicant
Boyd Industries, Inc.
Largo, FL, US
Received
May 27, 1997
Decision date
August 14, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GEY – Motor, Surgical Instrument, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Specialty
General, Plastic Surgery

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Questions and answers

When was Aqua Spray cleared by the FDA?

Aqua Spray (K971941) received a 510(k) decision of Substantially Equivalent on August 14, 1997, 79 days after the submission was received.

What is the product code of K971941?

The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.