The following data is part of a premarket notification filed by Laser-optik-systeme Gmbh & Co. Kg with the FDA for Standard Endoscope.
| Device ID | K972056 |
| 510k Number | K972056 |
| Device Name: | STANDARD ENDOSCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LASER-OPTIK-SYSTEME GMBH & CO. KG AM SAGEWERK 11 Mainz, DE 55124 |
| Contact | Marc Strelow |
| Correspondent | Marc Strelow LASER-OPTIK-SYSTEME GMBH & CO. KG AM SAGEWERK 11 Mainz, DE 55124 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-02 |
| Decision Date | 1997-07-30 |