The following data is part of a premarket notification filed by Daig Corp. with the FDA for Five-year Sterile Packaging Shelf Life.
| Device ID | K892528 |
| 510k Number | K892528 |
| Device Name: | FIVE-YEAR STERILE PACKAGING SHELF LIFE |
| Classification | Permanent Pacemaker Electrode |
| Applicant | DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Contact | John Fleischhacker |
| Correspondent | John Fleischhacker DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1990-01-18 |