The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Perfuse Percutaneous Decompression System.
| Device ID | K141762 |
| 510k Number | K141762 |
| Device Name: | PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM |
| Classification | Syringe, Piston |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Lonnie Witham |
| Correspondent | Lonnie Witham 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 | 2014-07-01 |
| Decision Date | 2014-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304999633 | K141762 | 000 |
| 00887868263026 | K141762 | 000 |
| 00887868263033 | K141762 | 000 |
| 00887868263040 | K141762 | 000 |
| 00887868263057 | K141762 | 000 |
| 00887868263064 | K141762 | 000 |
| 00887868263071 | K141762 | 000 |
| 00880304680333 | K141762 | 000 |
| 00880304999596 | K141762 | 000 |
| 00880304999602 | K141762 | 000 |
| 00880304999619 | K141762 | 000 |
| 00880304999626 | K141762 | 000 |
| 00887868273704 | K141762 | 000 |