The following data is part of a premarket notification filed by Galileo Electro-optics Corp. with the FDA for Galileo Endoscopes.
| Device ID | K962116 |
| 510k Number | K962116 |
| Device Name: | GALILEO ENDOSCOPES |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | GALILEO ELECTRO-OPTICS CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnarmara-cullinane |
| Correspondent | Mary Mcnarmara-cullinane GALILEO ELECTRO-OPTICS CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-31 |
| Decision Date | 1996-11-27 |
| Summary: | summary |