The following data is part of a premarket notification filed by Byron Medical with the FDA for Lipoplasty/ Liposuction Aspiration And Tumescent Infusion Cannulae And Needles.
Device ID | K981172 |
510k Number | K981172 |
Device Name: | LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES |
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 | 1998-04-01 |
Decision Date | 1998-06-30 |
Summary: | summary |