The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Access Concentration System, Model Acc-100, Access Disposable Set, Model Ads-2000.
| Device ID | K022348 |
| 510k Number | K022348 |
| Device Name: | ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000 |
| Classification | Apparatus, Autotransfusion |
| Applicant | INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Prosie Rey-fessler |
| Correspondent | Prosie Rey-fessler INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-19 |
| Decision Date | 2002-08-15 |
| Summary: | summary |