The following data is part of a premarket notification filed by I.c. Medical, Inc. with the FDA for I.c. Medical Auto Intra-abdominal Plume Eliminator.
| Device ID | K914118 |
| 510k Number | K914118 |
| Device Name: | I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | I.C. MEDICAL, INC. 2340 W. SHANGRI LA SUITE 202 Phoenix, AZ 85029 |
| Contact | Loan Cosmescu |
| Correspondent | Loan Cosmescu I.C. MEDICAL, INC. 2340 W. SHANGRI LA SUITE 202 Phoenix, AZ 85029 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-13 |
| Decision Date | 1992-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50749756231171 | K914118 | 000 |
| 50749756157976 | K914118 | 000 |
| 00817688022336 | K914118 | 000 |
| 00817688021964 | K914118 | 000 |
| 00817688021339 | K914118 | 000 |
| 00817688021315 | K914118 | 000 |
| 00817688021292 | K914118 | 000 |