The following data is part of a premarket notification filed by Pace Medical with the FDA for Miniature Models 4562/4563/4572/4573 Pacemaker.
Device ID | K913805 |
510k Number | K913805 |
Device Name: | MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER |
Classification | Pulse-generator, Pacemaker, External |
Applicant | PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
Contact | Robert C Mace |
Correspondent | Robert C Mace PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
Product Code | DTE |
CFR Regulation Number | 870.3600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-26 |
Decision Date | 1991-11-19 |