The following data is part of a premarket notification filed by Pacesetter, Inc. with the FDA for Df-1 Terminal Cap.
Device ID | K954551 |
510k Number | K954551 |
Device Name: | DF-1 TERMINAL CAP |
Classification | Permanent Pacemaker Electrode |
Applicant | PACESETTER, INC. 15900 VAKLLEY VIEW COURT Sylmar, CA 91342 -3577 |
Contact | Jacqueline J Jackson |
Correspondent | Jacqueline J Jackson PACESETTER, INC. 15900 VAKLLEY VIEW COURT Sylmar, CA 91342 -3577 |
Product Code | DTB |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-02 |
Decision Date | 1995-12-26 |