The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan-contec Ec-1000 Endoscopy Video Camera System.
| Device ID | K942740 |
| 510k Number | K942740 |
| Device Name: | SHARPLAN-CONTEC EC-1000 ENDOSCOPY VIDEO CAMERA SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SHARPLAN LASERS, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan SHARPLAN LASERS, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-10 |
| Decision Date | 1994-08-23 |