The following data is part of a premarket notification filed by Cosmaceutical Marketing, Inc. with the FDA for Lubriscan Ultra Scan Gel +, Model Rg2-60.
| Device ID | K980091 |
| 510k Number | K980091 |
| Device Name: | LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | COSMACEUTICAL MARKETING, INC. 10820 ALDER CIR. Dallas, TX 75238 |
| Contact | Michael Caswell |
| Correspondent | Michael Caswell COSMACEUTICAL MARKETING, INC. 10820 ALDER CIR. Dallas, TX 75238 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-09 |
| Decision Date | 1998-04-09 |
| Summary: | summary |