The following data is part of a premarket notification filed by Cell Bio-systems, Inc. with the FDA for Tulip Disposable Cannulas.
Device ID | K060089 |
510k Number | K060089 |
Device Name: | TULIP DISPOSABLE CANNULAS |
Classification | System, Suction, Lipoplasty |
Applicant | CELL BIO-SYSTEMS, INC. 1205 DE LA VINA STREET Santa Barbara, CA 93101 |
Contact | Christine Emanuel |
Correspondent | Christine Emanuel CELL BIO-SYSTEMS, INC. 1205 DE LA VINA STREET Santa Barbara, CA 93101 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-12 |
Decision Date | 2006-04-27 |
Summary: | summary |