The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Rbm.
Device ID | K020480 |
510k Number | K020480 |
Device Name: | RBM |
Classification | Retention Device, Suture |
Applicant | SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
Contact | William Mccallum |
Correspondent | William Mccallum SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
Product Code | KGS |
CFR Regulation Number | 878.4930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-13 |
Decision Date | 2002-03-12 |
Summary: | summary |