The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Permanent Pacing Lead, Models Petite, Petite R, J, Rj, Petite B, Rb, Jb, Rjb.
| Device ID | K020669 |
| 510k Number | K020669 |
| Device Name: | PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB |
| Classification | Permanent Pacemaker Electrode |
| 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 | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-01 |
| Decision Date | 2002-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885672103569 | K020669 | 000 |
| 00836559001997 | K020669 | 000 |
| 00836559002000 | K020669 | 000 |
| 00836559002017 | K020669 | 000 |
| 00836559002024 | K020669 | 000 |
| 00836559007425 | K020669 | 000 |
| 20802526563229 | K020669 | 000 |
| 20885672008349 | K020669 | 000 |
| 40836559009236 | K020669 | 000 |
| 70836559001989 | K020669 | 000 |
| 70836559001996 | K020669 | 000 |
| 70836559002009 | K020669 | 000 |
| 70836559002016 | K020669 | 000 |
| 70836559002023 | K020669 | 000 |
| 70836559007424 | K020669 | 000 |
| 70885672103568 | K020669 | 000 |
| 00836559001980 | K020669 | 000 |