The following data is part of a premarket notification filed by Scanlan Intl., Inc. with the FDA for Scanlan(r) Thoracoscopic Scissors, Clamp, Forceps, Needle Holder.
| Device ID | K945474 |
| 510k Number | K945474 |
| Device Name: | SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SCANLAN INTL., INC. ONE SCANLAN PLAZA St Paul, MN 55107 |
| Contact | Kenneth R Blake |
| Correspondent | Kenneth R Blake SCANLAN INTL., INC. ONE SCANLAN PLAZA St Paul, MN 55107 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-08 |
| Decision Date | 1994-12-05 |