The following data is part of a premarket notification filed by Gespac, Inc. with the FDA for Sr30/sr50/sr60 Auto Sediment Rate System, Modified.
| Device ID | K892522 |
| 510k Number | K892522 |
| Device Name: | SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED |
| Classification | Device, Automated Sedimentation Rate |
| Applicant | GESPAC, INC. 50 W. HOOVER AVE. Mesa, AZ 85210 |
| Contact | Cosma Pabouctsidis |
| Correspondent | Cosma Pabouctsidis GESPAC, INC. 50 W. HOOVER AVE. Mesa, AZ 85210 |
| Product Code | GKB |
| CFR Regulation Number | 864.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-05-24 |