Cleared Traditional

AQUA SPRAY

K971941 · Boyd Industries, Inc. · General & Plastic Surgery

Aug 1997

Decision

79d

Days

Class 1

Risk

About This 510(k) Submission

K971941 is an FDA 510(k) clearance for the AQUA SPRAY, a Motor, Surgical Instrument, Ac-powered (Class I — General Controls, product code GEY), submitted by Boyd Industries, Inc. (Largo, US). The FDA issued a Cleared decision on August 14, 1997, 79 days after receiving the submission on May 27, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K971941 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 1997
Decision Date	August 14, 1997
Days to Decision	79 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF