The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Malecot And Pezzer Drains.
Device ID | K070879 |
510k Number | K070879 |
Device Name: | BARD MALECOT AND PEZZER DRAINS |
Classification | Catheter, Malecot |
Applicant | C.R. BARD, INC. 13183 HARLAND DRIVE Covington, GA 30014 -6421 |
Contact | John Knorpp |
Correspondent | John Knorpp C.R. BARD, INC. 13183 HARLAND DRIVE Covington, GA 30014 -6421 |
Product Code | FEW |
CFR Regulation Number | 876.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-30 |
Decision Date | 2007-04-24 |
Summary: | summary |