The following data is part of a premarket notification filed by Polysciences, Inc. with the FDA for Centricell(tm).
| Device ID | K871290 |
| 510k Number | K871290 |
| Device Name: | CENTRICELL(TM) |
| Classification | Clinical Sample Concentrator |
| Applicant | POLYSCIENCES, INC. 400 VALLEY RD. Warrington, PA 18976 -2590 |
| Contact | Michael H Ott |
| Correspondent | Michael H Ott POLYSCIENCES, INC. 400 VALLEY RD. Warrington, PA 18976 -2590 |
| Product Code | JJH |
| CFR Regulation Number | 862.2310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-31 |
| Decision Date | 1987-08-05 |