The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for 8mm Quantum Pulse/suprima Ii Pulse Generators.
| Device ID | K911122 |
| 510k Number | K911122 |
| Device Name: | 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
| Contact | Alaine Medio |
| Correspondent | Alaine Medio INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-12 |
| Decision Date | 1991-05-16 |