The following data is part of a premarket notification filed by Byron Medical with the FDA for Psi-tec Liposuction Aspirator.
| Device ID | K981215 |
| 510k Number | K981215 |
| Device Name: | PSI-TEC LIPOSUCTION ASPIRATOR |
| Classification | System, Suction, Lipoplasty |
| Applicant | BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Contact | Steve Bollinger |
| Correspondent | Steve Bollinger BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-02 |
| Decision Date | 1998-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00081317023364 | K981215 | 000 |
| 00081317020028 | K981215 | 000 |