The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Astra T2, T3, T4, T6 Pulse Generators New Package.
| Device ID | K890785 |
| 510k Number | K890785 |
| Device Name: | ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Contact | Helen Bucko |
| Correspondent | Helen Bucko CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-15 |
| Decision Date | 1989-03-10 |