The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Threaded Paddle Pairs, Internal Adult Pedi Infant.
| Device ID | K902590 |
| 510k Number | K902590 |
| Device Name: | THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Carole Paasch-homan |
| Correspondent | Carole Paasch-homan MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-12 |
| Decision Date | 1990-07-18 |