The following data is part of a premarket notification filed by I.c. Medical, Inc. with the FDA for Si Controller Model Si 500.
| Device ID | K960492 |
| 510k Number | K960492 |
| Device Name: | SI CONTROLLER MODEL SI 500 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | I.C. MEDICAL, INC. 5170 W. PHELPS RD. SUITE D Glendale, AZ 85306 |
| Contact | Kurt Hasper |
| Correspondent | Kurt Hasper I.C. MEDICAL, INC. 5170 W. PHELPS RD. SUITE D Glendale, AZ 85306 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-02 |
| Decision Date | 1996-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00749756252867 | K960492 | 000 |