The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Resorbable Bone Plug.
Device ID | K905740 |
510k Number | K905740 |
Device Name: | RESORBABLE BONE PLUG |
Classification | Hearing Aid, Air Conduction |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Carol Vierling |
Correspondent | Carol Vierling ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-24 |
Decision Date | 1991-04-03 |