The following data is part of a premarket notification filed by Berkline Corp. with the FDA for Easy Life.
Device ID | K023521 |
510k Number | K023521 |
Device Name: | EASY LIFE |
Classification | Chair, Positioning, Electric |
Applicant | BERKLINE CORP. ONE BERKLINE DR. Morristown, TN 37813 |
Contact | David Popkin |
Correspondent | David Popkin BERKLINE CORP. ONE BERKLINE DR. Morristown, TN 37813 |
Product Code | INO |
CFR Regulation Number | 890.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-21 |
Decision Date | 2002-11-19 |
Summary: | summary |