The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Ecg & Ultrasound Gels, Creams & Lotion.
| Device ID | K803151 |
| 510k Number | K803151 |
| Device Name: | ECG & ULTRASOUND GELS, CREAMS & LOTION |
| Classification | Media, Electroconductive |
| Applicant | ABCO DEALERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-12 |
| Decision Date | 1980-12-30 |