The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Pop Rivet.
Device ID | K981798 |
510k Number | K981798 |
Device Name: | LACTOSORB POP RIVET |
Classification | Staple, Fixation, Bone |
Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
Contact | Julie K Ryan |
Correspondent | Julie K Ryan BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
Product Code | JDR |
Subsequent Product Code | HRX |
Subsequent Product Code | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-05-21 |
Decision Date | 1998-07-13 |
Summary: | summary |