The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for #335-01 Silic Rub Isola Sleeve For Int #281-03 Siz.
| Device ID | K853034 |
| 510k Number | K853034 |
| Device Name: | #335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
| Contact | Lisa S Jones |
| Correspondent | Lisa S Jones 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 | 1985-07-18 |
| Decision Date | 1985-07-25 |