The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Platelet Concentrate Separation Kit For Celsep Centrifuge System.
| Device ID | K021927 |
| 510k Number | K021927 |
| Device Name: | PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM |
| Classification | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Applicant | BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Lonnie Witham |
| Correspondent | Lonnie Witham BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | LXG |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-12 |
| Decision Date | 2002-07-12 |
| Summary: | summary |