The following data is part of a premarket notification filed by Gy-ro Industry, Inc. with the FDA for Gy-ro Safe.
| Device ID | K883785 |
| 510k Number | K883785 |
| Device Name: | GY-RO SAFE |
| Classification | Burr, Corneal, Battery-powered |
| Applicant | GY-RO INDUSTRY, INC. BOX 87794 Houston, TX 77287 |
| Contact | Wm. N West |
| Correspondent | Wm. N West GY-RO INDUSTRY, INC. BOX 87794 Houston, TX 77287 |
| Product Code | HOG |
| CFR Regulation Number | 886.4070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-07 |
| Decision Date | 1989-01-05 |