The following data is part of a premarket notification filed by C.r. Bard Inc with the FDA for Permasorb Disposable Fixation Device.
Device ID | K123718 |
510k Number | K123718 |
Device Name: | PERMASORB DISPOSABLE FIXATION DEVICE |
Classification | Staple, Implantable |
Applicant | C.R. BARD INC 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
Contact | Radhika Pondicherry |
Correspondent | Radhika Pondicherry C.R. BARD INC 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
Product Code | GDW |
CFR Regulation Number | 878.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-04 |
Decision Date | 2013-01-22 |
Summary: | summary |