The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Protectoral Ultrasonic Handpiece Processor.
| Device ID | K932333 |
| 510k Number | K932333 |
| Device Name: | PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
| Contact | Fred W Rachford |
| Correspondent | Fred W Rachford GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-13 |
| Decision Date | 1995-08-15 |