The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Implant Aid Splicing Crimp & Sleeve.
| Device ID | K813518 |
| 510k Number | K813518 |
| Device Name: | IMPLANT AID SPLICING CRIMP & SLEEVE |
| Classification | Materials, Repair Or Replacement, Pacemaker |
| Applicant | INTERMEDICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KFJ |
| CFR Regulation Number | 870.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-16 |
| Decision Date | 1982-01-12 |