The following data is part of a premarket notification filed by Electro Fiberoptics Corp. with the FDA for Fiber Optic Endoscope.
| Device ID | K921918 |
| 510k Number | K921918 |
| Device Name: | FIBER OPTIC ENDOSCOPE |
| Classification | Endoscope, Rigid |
| Applicant | ELECTRO FIBEROPTICS CORP. 56 HUDSON ST. Northborough, MA 01532 |
| Contact | Kenneth J Durbin |
| Correspondent | Kenneth J Durbin ELECTRO FIBEROPTICS CORP. 56 HUDSON ST. Northborough, MA 01532 |
| Product Code | GCM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-23 |
| Decision Date | 1993-08-17 |