The following data is part of a premarket notification filed by Stony Brook Trading And Development Corp. with the FDA for Stony Brook Model Eecp-mc1.
Device ID | K882401 |
510k Number | K882401 |
Device Name: | STONY BROOK MODEL EECP-MC1 |
Classification | Device, Counter-pulsating, External |
Applicant | STONY BROOK TRADING AND DEVELOPMENT CORP. 25 ASHAROKEN AVE. Northport, NY 11766 |
Contact | Hui, Phd |
Correspondent | Hui, Phd STONY BROOK TRADING AND DEVELOPMENT CORP. 25 ASHAROKEN AVE. Northport, NY 11766 |
Product Code | DRN |
CFR Regulation Number | 870.5225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-10 |
Decision Date | 1989-03-03 |