The following data is part of a premarket notification filed by West Texas Lighthouse For The Blind with the FDA for Rocket Surgical Skin Marking Pen.
| Device ID | K912730 |
| 510k Number | K912730 |
| Device Name: | ROCKET SURGICAL SKIN MARKING PEN |
| Classification | Marker, Skin |
| Applicant | WEST TEXAS LIGHTHOUSE FOR THE BLIND 2001 AUSTIN ST. San Angelo, TX 76903 |
| Contact | Ronald J Beard |
| Correspondent | Ronald J Beard WEST TEXAS LIGHTHOUSE FOR THE BLIND 2001 AUSTIN ST. San Angelo, TX 76903 |
| Product Code | FZZ |
| CFR Regulation Number | 878.4660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-20 |
| Decision Date | 1991-11-07 |