The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Electrode/extension Cables, Models Atar.
Device ID | K070926 |
510k Number | K070926 |
Device Name: | ELECTRODE/EXTENSION CABLES, MODELS ATAR |
Classification | Cable, 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 | IKD |
CFR Regulation Number | 890.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-04-03 |
Decision Date | 2007-06-07 |