The following data is part of a premarket notification filed by Coratomic, Inc. with the FDA for Modification Of Sterility Cycle Parameters.
| Device ID | K863365 |
| 510k Number | K863365 |
| Device Name: | MODIFICATION OF STERILITY CYCLE PARAMETERS |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | CORATOMIC, INC. 300 INDIAN SPRINGS RD. P.O. BOX 434 Indiana, PA 15701 |
| Contact | Joseph Klingensmith |
| Correspondent | Joseph Klingensmith CORATOMIC, INC. 300 INDIAN SPRINGS RD. P.O. BOX 434 Indiana, PA 15701 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-02 |
| Decision Date | 1986-10-08 |