The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Modified Models 253-19 & 254-20 Quantum Generators.
| Device ID | K873528 |
| 510k Number | K873528 |
| Device Name: | MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
| Contact | Ken Bishop |
| Correspondent | Ken Bishop 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 | 1987-09-01 |
| Decision Date | 1987-10-09 |