The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Ultrasound Couplant Sheet/solid Ultrasound Couplan.
| Device ID | K853702 |
| 510k Number | K853702 |
| Device Name: | ULTRASOUND COUPLANT SHEET/SOLID ULTRASOUND COUPLAN |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 69 SPRING ST. Ramsey, NJ 07446 |
| Contact | Raymond F Chase |
| Correspondent | Raymond F Chase JOHNSON & JOHNSON PROFESSIONALS, INC. 69 SPRING ST. Ramsey, NJ 07446 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-04 |
| Decision Date | 1986-02-13 |