The following data is part of a premarket notification filed by Molded Products Inc. with the FDA for Modification To Male To Male Luer Adapter.
| Device ID | K003712 |
| 510k Number | K003712 |
| Device Name: | MODIFICATION TO MALE TO MALE LUER ADAPTER |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | MOLDED PRODUCTS INC. P.O. BOX 15 Harlan, IA 51537 |
| Contact | Elise Johnston |
| Correspondent | Elise Johnston MOLDED PRODUCTS INC. P.O. BOX 15 Harlan, IA 51537 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-01 |
| Decision Date | 2001-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B144UM872360 | K003712 | 000 |
| B144MPC1403 | K003712 | 000 |
| B144MPC1503 | K003712 | 000 |
| B144MPC1553 | K003712 | 000 |
| B144MPC1603 | K003712 | 000 |
| B144MPC660S3 | K003712 | 000 |
| B144MPC850163 | K003712 | 000 |
| B144MPC850SP3 | K003712 | 000 |
| B144MPC8551 | K003712 | 000 |
| B144MPC825S1 | K003712 | 000 |