The following data is part of a premarket notification filed by Innovations For Access, Inc. with the FDA for Hemoband, Models Hb-ns And Hb-nsxl.
| Device ID | K081740 |
| 510k Number | K081740 |
| Device Name: | HEMOBAND, MODELS HB-NS AND HB-NSXL |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | INNOVATIONS FOR ACCESS, INC. 515 NW SALTZMAN ROAD #797 Portland, OR 97229 -6098 |
| Contact | Hal J Oien |
| Correspondent | Hal J Oien INNOVATIONS FOR ACCESS, INC. 515 NW SALTZMAN ROAD #797 Portland, OR 97229 -6098 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-19 |
| Decision Date | 2009-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865165000216 | K081740 | 000 |
| 00865165000209 | K081740 | 000 |