The following data is part of a premarket notification filed by Daig Corp. with the FDA for Adapter Kit.
Device ID | K781864 |
510k Number | K781864 |
Device Name: | ADAPTER KIT |
Classification | Pacemaker Lead Adaptor |
Applicant | DAIG CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DTD |
CFR Regulation Number | 870.3620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-11-06 |
Decision Date | 1978-12-19 |