The following data is part of a premarket notification filed by The Ludlow Company Lp with the FDA for Uni-patch Ultrasound Coupling Gel.
| Device ID | K021132 |
| 510k Number | K021132 |
| Device Name: | UNI-PATCH ULTRASOUND COUPLING GEL |
| Classification | Media, Coupling, Ultrasound |
| Applicant | THE LUDLOW COMPANY LP TWO LUDLOW PARK DR. Chicopee, MA 01022 |
| Contact | M. Beth Rice |
| Correspondent | M. Beth Rice THE LUDLOW COMPANY LP TWO LUDLOW PARK DR. Chicopee, MA 01022 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-09 |
| Decision Date | 2002-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884527017284 | K021132 | 000 |
| 20884527017291 | K021132 | 000 |