The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Sheets.
Device ID | K992158 |
510k Number | K992158 |
Device Name: | LACTOSORB SHEETS |
Classification | Plate, Bone |
Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
Contact | Michelle L Mckinley |
Correspondent | Michelle L Mckinley BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-25 |
Decision Date | 1999-08-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841036055868 | K992158 | 000 |
00841036055851 | K992158 | 000 |
00841036055844 | K992158 | 000 |