The following data is part of a premarket notification filed by Boyd Industries, Inc. with the FDA for Aqua Spray.
| Device ID | K971941 |
| 510k Number | K971941 |
| Device Name: | AQUA SPRAY |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | BOYD INDUSTRIES, INC. 12275 75TH ST. NORTH Largo, FL 33773 -3031 |
| Contact | Bruce V Livingston |
| Correspondent | Bruce V Livingston BOYD INDUSTRIES, INC. 12275 75TH ST. NORTH Largo, FL 33773 -3031 |
| Product Code | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-27 |
| Decision Date | 1997-08-14 |
| Summary: | summary |