The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Vacora Vacuum Assisted Biopsy System.
Device ID | K082681 |
510k Number | K082681 |
Device Name: | VACORA VACUUM ASSISTED BIOPSY SYSTEM |
Classification | Instrument, Biopsy |
Applicant | C.R. BARD, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 -1740 |
Contact | Cindy Moss |
Correspondent | Cindy Moss C.R. BARD, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 -1740 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-09-15 |
Decision Date | 2008-10-15 |
Summary: | summary |