The following data is part of a premarket notification filed by I.c. Medical, Inc. with the FDA for Crystal Vision #250d Smoke Evacuator System With Accessories.
| Device ID | K003840 |
| 510k Number | K003840 |
| Device Name: | CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | I.C. MEDICAL, INC. 2002 W. QUAIL AVE. Phoenix, AZ 85027 -2610 |
| Contact | Craig Harshman |
| Correspondent | Craig Harshman I.C. MEDICAL, INC. 2002 W. QUAIL AVE. Phoenix, AZ 85027 -2610 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-12 |
| Decision Date | 2001-02-01 |