The following data is part of a premarket notification filed by Galileo Electro-optics Corp. with the FDA for Galileo Hysteroscopes And Laparoscopes.
| Device ID | K962256 |
| 510k Number | K962256 |
| Device Name: | GALILEO HYSTEROSCOPES AND LAPAROSCOPES |
| Classification | Hysteroscope (and Accessories) |
| Applicant | GALILEO ELECTRO-OPTICS CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane GALILEO ELECTRO-OPTICS CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-12 |
| Decision Date | 1996-12-06 |
| Summary: | summary |