The following data is part of a premarket notification filed by Conmed Integrated Systems, Canada, Ulc with the FDA for Service Manager Sm40se.
| Device ID | K053464 |
| 510k Number | K053464 |
| Device Name: | SERVICE MANAGER SM40SE |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | CONMED INTEGRATED SYSTEMS, CANADA, ULC 11311 CONCEPT BLVD Largo, FL 33773 -4908 |
| Contact | Michael T Taggart |
| Correspondent | Michael T Taggart CONMED INTEGRATED SYSTEMS, CANADA, ULC 11311 CONCEPT BLVD Largo, FL 33773 -4908 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-13 |
| Decision Date | 2006-06-06 |
| Summary: | summary |