The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Medicam Laparoscopy Endoscopes.
| Device ID | K912933 |
| 510k Number | K912933 |
| Device Name: | MEDICAM LAPAROSCOPY ENDOSCOPES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Contact | Sam Son |
| Correspondent | Sam Son KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-05 |
| Decision Date | 1991-10-15 |