The following data is part of a premarket notification filed by Precision Dynamics Corp. with the FDA for Securline Surgical Skin Marker 1000.
| Device ID | K840820 |
| 510k Number | K840820 |
| Device Name: | SECURLINE SURGICAL SKIN MARKER 1000 |
| Classification | Marker, Skin |
| Applicant | PRECISION DYNAMICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FZZ |
| CFR Regulation Number | 878.4660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-24 |
| Decision Date | 1984-04-25 |