The following data is part of a premarket notification filed by Truett Laboratories, Inc. with the FDA for Radiological Marking Pen.
| Device ID | K852160 |
| 510k Number | K852160 |
| Device Name: | RADIOLOGICAL MARKING PEN |
| Classification | System, X-ray, Film Marking, Radiographic |
| Applicant | TRUETT LABORATORIES, INC. 798 NORTH CONEY AVE. Azusa, CA 91702 |
| Contact | Neal Goodwin |
| Correspondent | Neal Goodwin TRUETT LABORATORIES, INC. 798 NORTH CONEY AVE. Azusa, CA 91702 |
| Product Code | JAC |
| CFR Regulation Number | 892.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-28 |
| Decision Date | 1985-07-18 |