The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Disposable Blood Line Connectors.
| Device ID | K821495 |
| 510k Number | K821495 |
| Device Name: | DISPOSABLE BLOOD LINE CONNECTORS |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-19 |
| Decision Date | 1982-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B066C310B1 | K821495 | 000 |
| B066C225E5 | K821495 | 000 |
| B066C230B1 | K821495 | 000 |
| B066C235B1 | K821495 | 000 |
| B066C240B1 | K821495 | 000 |
| B066C245B1 | K821495 | 000 |
| B066C250B1 | K821495 | 000 |
| B066C110B1 | K821495 | 000 |
| B066C115B1 | K821495 | 000 |
| B066C120B1 | K821495 | 000 |
| B066C125B1 | K821495 | 000 |
| B066C125E1 | K821495 | 000 |
| B066C130B1 | K821495 | 000 |
| B066C135B1 | K821495 | 000 |
| B066C225B1 | K821495 | 000 |
| B066C220B1 | K821495 | 000 |
| B066C490B1 | K821495 | 000 |
| B066C320B1 | K821495 | 000 |
| B066C325B1 | K821495 | 000 |
| B066C330B1 | K821495 | 000 |
| B066C335B1 | K821495 | 000 |
| B066C340B1 | K821495 | 000 |
| B066C345B1 | K821495 | 000 |
| B066C420B1 | K821495 | 000 |
| B066C430B1 | K821495 | 000 |
| B066C440B1 | K821495 | 000 |
| B066C445B1 | K821495 | 000 |
| B066C460B1 | K821495 | 000 |
| B066C470B1 | K821495 | 000 |
| B066C480B1 | K821495 | 000 |
| B066C135E5 | K821495 | 000 |
| B066C140B1 | K821495 | 000 |
| B066C145B1 | K821495 | 000 |
| B066C325S0 | K821495 | 000 |
| B066C330S0 | K821495 | 000 |
| B066C335S0 | K821495 | 000 |
| B066C340S0 | K821495 | 000 |
| B066C345S0 | K821495 | 000 |
| B066C420S0 | K821495 | 000 |
| B066C430S0 | K821495 | 000 |
| B066C435S0 | K821495 | 000 |
| B066C440S0 | K821495 | 000 |
| B066C445S0 | K821495 | 000 |
| B066C460S0 | K821495 | 000 |
| B066C465S0 | K821495 | 000 |
| B066C470S0 | K821495 | 000 |
| B066C320S0 | K821495 | 000 |
| B066C310S0 | K821495 | 000 |
| B066C245S0 | K821495 | 000 |
| B066C110S0 | K821495 | 000 |
| B066C115S0 | K821495 | 000 |
| B066C120S0 | K821495 | 000 |
| B066C125S0 | K821495 | 000 |
| B066C130S0 | K821495 | 000 |
| B066C135S0 | K821495 | 000 |
| B066C140S0 | K821495 | 000 |
| B066C145S0 | K821495 | 000 |
| B066C220S0 | K821495 | 000 |
| B066C225S0 | K821495 | 000 |
| B066C230S0 | K821495 | 000 |
| B066C235S0 | K821495 | 000 |
| B066C240S0 | K821495 | 000 |
| B066C480S0 | K821495 | 000 |