The following data is part of a premarket notification filed by Galileo Electro-optics Corp. with the FDA for Galileo Arthroscopes.
| Device ID | K934707 |
| 510k Number | K934707 |
| Device Name: | GALILEO ARTHROSCOPES |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-30 |
| Decision Date | 1994-10-07 |