The following data is part of a premarket notification filed by Innovations In Access, Inc. with the FDA for Hemo-band.
| Device ID | K920614 |
| 510k Number | K920614 |
| Device Name: | HEMO-BAND |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | INNOVATIONS IN ACCESS, INC. 18603 WILLAMETTE DR. West Linn, OR 97068 |
| Contact | Tom Tribou |
| Correspondent | Tom Tribou INNOVATIONS IN ACCESS, INC. 18603 WILLAMETTE DR. West Linn, OR 97068 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-11 |
| Decision Date | 1992-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865165000223 | K920614 | 000 |