The following data is part of a premarket notification filed by Regional Master Corp. with the FDA for The Gripper.
Device ID | K853422 |
510k Number | K853422 |
Device Name: | THE GRIPPER |
Classification | Stimulator, Nerve, Battery-powered |
Applicant | REGIONAL MASTER CORP. P.O. BOX 431832 Miami, FL 33143 |
Contact | Margarita Plaza |
Correspondent | Margarita Plaza REGIONAL MASTER CORP. P.O. BOX 431832 Miami, FL 33143 |
Product Code | BXN |
CFR Regulation Number | 868.2775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-14 |
Decision Date | 1986-01-15 |