The following data is part of a premarket notification filed by Reliance Medical Corp. with the FDA for Bi-phasic Infiltrator.
| Device ID | K012044 |
| 510k Number | K012044 |
| Device Name: | BI-PHASIC INFILTRATOR |
| Classification | Pump, Infusion |
| Applicant | RELIANCE MEDICAL CORP. 730 INDEPENDENT AVE. Grand Junction, CO 81505 |
| Contact | Robert W Nicks |
| Correspondent | Robert W Nicks RELIANCE MEDICAL CORP. 730 INDEPENDENT AVE. Grand Junction, CO 81505 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-29 |
| Decision Date | 2001-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859898006430 | K012044 | 000 |
| 00859898006423 | K012044 | 000 |