The following data is part of a premarket notification filed by Scribner Browne Medical Design, Inc. with the FDA for Angiorest Table Pad System.
Device ID | K942674 |
510k Number | K942674 |
Device Name: | ANGIOREST TABLE PAD SYSTEM |
Classification | System, X-ray, Fluoroscopic, Image-intensified |
Applicant | SCRIBNER BROWNE MEDICAL DESIGN, INC. 5589 ARAPAHOE, #207 Boulder, CO 80303 |
Contact | Robert M Scribner |
Correspondent | Robert M Scribner SCRIBNER BROWNE MEDICAL DESIGN, INC. 5589 ARAPAHOE, #207 Boulder, CO 80303 |
Product Code | JAA |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-06 |
Decision Date | 1994-07-29 |