The following data is part of a premarket notification filed by Daig Corp. with the FDA for Daig Pacemaker Lead Adaptor.
Device ID | K870562 |
510k Number | K870562 |
Device Name: | DAIG PACEMAKER LEAD ADAPTOR |
Classification | Pacemaker Lead Adaptor |
Applicant | DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
Contact | J Fleischhacker |
Correspondent | J Fleischhacker DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
Product Code | DTD |
CFR Regulation Number | 870.3620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-10 |
Decision Date | 1987-03-03 |