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 | K844865 |
| 510k Number | K844865 |
| Device Name: | SECURLINE SURGICAL SKIN MARKER 1000 |
| Classification | Marker, Skin |
| Applicant | PRECISION DYNAMICS CORP. 13880 DEL SUR ST. San Fernando, CA 91340 -3490 |
| Contact | Gino Franco |
| Correspondent | Gino Franco PRECISION DYNAMICS CORP. 13880 DEL SUR ST. San Fernando, CA 91340 -3490 |
| Product Code | FZZ |
| CFR Regulation Number | 878.4660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-14 |
| Decision Date | 1985-01-14 |