The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Coaxial Applicator System.
| Device ID | K091722 |
| 510k Number | K091722 |
| Device Name: | COAXIAL APPLICATOR SYSTEM |
| Classification | Syringe, Piston |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Elizabeth Wray |
| Correspondent | Elizabeth Wray BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-11 |
| Decision Date | 2010-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304508781 | K091722 | 000 |
| 00887868306730 | K091722 | 000 |
| 00880304484757 | K091722 | 000 |