The following data is part of a premarket notification filed by Novadaq Technologies, Inc. with the FDA for Spy Scope Intra-operative Operating System.
| Device ID | K091515 |
| 510k Number | K091515 |
| Device Name: | SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NOVADAQ TECHNOLOGIES, INC. 2585 SKYMARK AVENUE, STE. 306 Mississauga, Ontario, CA L4w 4l5 |
| Contact | John Fengler |
| Correspondent | John Fengler NOVADAQ TECHNOLOGIES, INC. 2585 SKYMARK AVENUE, STE. 306 Mississauga, Ontario, CA L4w 4l5 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-22 |
| Decision Date | 2009-07-09 |
| Summary: | summary |