The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Pacing Lead Bipolar Adapters And Extensions.
| Device ID | K010787 |
| 510k Number | K010787 |
| Device Name: | PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS |
| Classification | Pacemaker Lead Adaptor |
| Applicant | Oscor Inc. 3816 DeSoto Blvd. Palm Harbor, FL 34683 |
| Contact | Mila Doskocil |
| Correspondent | Mila Doskocil Oscor Inc. 3816 DeSoto Blvd. 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 | 2001-03-15 |
| Decision Date | 2001-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885672008369 | K010787 | 000 |
| 00885672008352 | K010787 | 000 |
| 00836559005544 | K010787 | 000 |
| 10885672102453 | K010787 | 000 |