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 |