The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Is4/df4 Port Plug.
| Device ID | K143463 |
| 510k Number | K143463 |
| Device Name: | IS4/DF4 Port Plug |
| Classification | Pacemaker Lead Adaptor |
| Applicant | Oscor Inc. 3816 De Soto Boulevard Palm Harbor, FL 34683 |
| Contact | Dorit Segal |
| Correspondent | Dorit Segal Oscor Inc. 3816 De Soto Boulevard Palm Harbor, FL 34683 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-04 |
| Decision Date | 2015-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885672008260 | K143463 | 000 |
| 00885672007003 | K143463 | 000 |