The following data is part of a premarket notification filed by Onyx Industries, Inc. with the FDA for Studex Ear Piercing Guns.
| Device ID | K860622 |
| 510k Number | K860622 |
| Device Name: | STUDEX EAR PIERCING GUNS |
| Classification | Perforator, Ear-lobe |
| Applicant | ONYX INDUSTRIES, INC. 25311 SOUTH NORMANDIE AVE. Harbor City, CA 90710 |
| Contact | Dana Maltun |
| Correspondent | Dana Maltun ONYX INDUSTRIES, INC. 25311 SOUTH NORMANDIE AVE. Harbor City, CA 90710 |
| Product Code | JYS |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-19 |
| Decision Date | 1986-10-17 |