The following data is part of a premarket notification filed by Galileo Electro-optics Corp. with the FDA for Galileo Endoscopes.
| Device ID | K934649 |
| 510k Number | K934649 |
| Device Name: | GALILEO ENDOSCOPES |
| Classification | Cystourethroscope |
| Applicant | GALILEO ELECTRO-OPTICS CORP. P.O. BOX 550 GALILEO PARK Sturbridge, MA 01566 |
| Contact | Robert D Salvucci |
| Correspondent | Robert D Salvucci GALILEO ELECTRO-OPTICS CORP. P.O. BOX 550 GALILEO PARK Sturbridge, MA 01566 |
| Product Code | FBO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-29 |
| Decision Date | 1994-10-13 |