The following data is part of a premarket notification filed by Surgichip, Inc. with the FDA for Surgichip Tag Surgical Marker.
| Device ID | K042555 |
| 510k Number | K042555 |
| Device Name: | SURGICHIP TAG SURGICAL MARKER |
| Classification | Marker, Skin |
| Applicant | SURGICHIP, INC. 4398 HICKORY DRIVE Palm Gardens, FL 33418 |
| Contact | Bruce Waxman |
| Correspondent | Bruce Waxman SURGICHIP, INC. 4398 HICKORY DRIVE Palm Gardens, FL 33418 |
| Product Code | FZZ |
| CFR Regulation Number | 878.4660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-20 |
| Decision Date | 2004-11-09 |
| Summary: | summary |