The following data is part of a premarket notification filed by Byron Medical with the FDA for Accelerator Reciprocating Cannula.
Device ID | K001803 |
510k Number | K001803 |
Device Name: | ACCELERATOR RECIPROCATING CANNULA |
Classification | System, Suction, Lipoplasty |
Applicant | BYRON MEDICAL 602 W RILLITO ST. Tucson, AZ 85705 |
Contact | Regina S Harris |
Correspondent | Regina S Harris BYRON MEDICAL 602 W RILLITO ST. Tucson, AZ 85705 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-14 |
Decision Date | 2000-08-04 |