The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Laparoscopic Trocar Starter Scalpel.
| Device ID | K936154 |
| 510k Number | K936154 |
| Device Name: | LAPAROSCOPIC TROCAR STARTER SCALPEL |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Marcia Leatham |
| Correspondent | Marcia Leatham BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-27 |
| Decision Date | 1994-02-04 |