The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for K-stik Defibrillation Pads.
| Device ID | K863899 |
| 510k Number | K863899 |
| Device Name: | K-STIK DEFIBRILLATION PADS |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | KATECHO, INC. 2601 BELL AVE. P.O BOX 21247 Des Moines, IA 50315 |
| Contact | Lorne Scharnberg |
| Correspondent | Lorne Scharnberg KATECHO, INC. 2601 BELL AVE. P.O BOX 21247 Des Moines, IA 50315 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-07 |
| Decision Date | 1986-11-12 |