The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Bmp Cable System.
Device ID | K982545 |
510k Number | K982545 |
Device Name: | BMP CABLE SYSTEM |
Classification | Cerclage, Fixation |
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 | JDQ |
CFR Regulation Number | 888.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-21 |
Decision Date | 1998-10-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304360686 | K982545 | 000 |
00880304267503 | K982545 | 000 |
00880304267497 | K982545 | 000 |
00880304267480 | K982545 | 000 |
00880304267473 | K982545 | 000 |
00880304267466 | K982545 | 000 |
00880304267459 | K982545 | 000 |
00880304267442 | K982545 | 000 |
00880304267435 | K982545 | 000 |
00880304223745 | K982545 | 000 |
00880304223653 | K982545 | 000 |
00880304223608 | K982545 | 000 |
00880304005808 | K982545 | 000 |
00880304005709 | K982545 | 000 |
00880304005693 | K982545 | 000 |
00880304005501 | K982545 | 000 |
00880304004054 | K982545 | 000 |
00880304000377 | K982545 | 000 |
00880304267510 | K982545 | 000 |
00880304267527 | K982545 | 000 |
00880304267541 | K982545 | 000 |
00880304360679 | K982545 | 000 |
00880304360549 | K982545 | 000 |
00880304267695 | K982545 | 000 |
00880304267688 | K982545 | 000 |
00880304267671 | K982545 | 000 |
00880304267664 | K982545 | 000 |
00880304267657 | K982545 | 000 |
00880304267640 | K982545 | 000 |
00880304267633 | K982545 | 000 |
00880304267626 | K982545 | 000 |
00880304267619 | K982545 | 000 |
00880304267602 | K982545 | 000 |
00880304267596 | K982545 | 000 |
00880304267589 | K982545 | 000 |
00880304267572 | K982545 | 000 |
00880304267565 | K982545 | 000 |
00880304267558 | K982545 | 000 |
00880304000100 | K982545 | 000 |