The following data is part of a premarket notification filed by Isomedix Operations Inc. with the FDA for Smartvac Smoke Evacuation System.
| Device ID | K970352 |
| 510k Number | K970352 |
| Device Name: | SMARTVAC SMOKE EVACUATION SYSTEM |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | ISOMEDIX OPERATIONS INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane, Rac |
| Correspondent | Mary Mcnamara-cullinane, Rac ISOMEDIX OPERATIONS INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-30 |
| Decision Date | 1997-11-04 |
| Summary: | summary |