The following data is part of a premarket notification filed by Scientific Technology Ltd. with the FDA for Fastrecon 88 Periferal.
Device ID | K902848 |
510k Number | K902848 |
Device Name: | FASTRECON 88 PERIFERAL |
Classification | System, X-ray, Tomography, Computed |
Applicant | SCIENTIFIC TECHNOLOGY LTD. CONSULTING AND DESIGN 2121 RICHWOOD DRIVE Garland, TX 75044 |
Contact | James R Herrington |
Correspondent | James R Herrington SCIENTIFIC TECHNOLOGY LTD. CONSULTING AND DESIGN 2121 RICHWOOD DRIVE Garland, TX 75044 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-28 |
Decision Date | 1990-08-01 |