The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Pacing Lead Extensions, Bipolar, Pacing Lead Adaptors, Unipolar/bipolar,pacing Lead Adaptors, Unipolar/bipolar.
| Device ID | K024156 |
| 510k Number | K024156 |
| Device Name: | PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR |
| Classification | Pacemaker Lead Adaptor |
| Applicant | Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Contact | Mila Doskocil |
| Correspondent | Mila Doskocil Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-17 |
| Decision Date | 2003-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00802526505300 | K024156 | 000 |
| 00802526497513 | K024156 | 000 |
| 00802526497506 | K024156 | 000 |
| 00885672102463 | K024156 | 000 |
| 00885672008338 | K024156 | 000 |
| 00885672008321 | K024156 | 000 |
| 00885672008314 | K024156 | 000 |
| 00836559006428 | K024156 | 000 |