The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Recovery Cone Removal System.
Device ID | K152136 |
510k Number | K152136 |
Device Name: | Recovery Cone Removal System |
Classification | Device, Percutaneous Retrieval |
Applicant | C.R. Bard, Inc. 1625 West Third Street Tempe, AZ 85281 |
Contact | Joni Creal |
Correspondent | Joni Creal C.R. Bard, Inc. 1625 West Third Street Tempe, AZ 85281 |
Product Code | MMX |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-31 |
Decision Date | 2016-02-18 |
Summary: | summary |