The following data is part of a premarket notification filed by Gespac, Inc. with the FDA for Sr30/sr50/sr60 Automated Sedimentation Rate.
Device ID | K890503 |
510k Number | K890503 |
Device Name: | SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE |
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 | 1989-02-01 |
Decision Date | 1989-02-10 |