The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Rv Pacing Lead.
Device ID | K962467 |
510k Number | K962467 |
Device Name: | RV PACING LEAD |
Classification | Electrode, Pacemaker, Temporary |
Applicant | ABBOTT LABORATORIES D-389, AP-30 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -3537 |
Contact | Dave Guzek |
Correspondent | Dave Guzek ABBOTT LABORATORIES D-389, AP-30 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -3537 |
Product Code | LDF |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-25 |
Decision Date | 1996-09-17 |