The following data is part of a premarket notification filed by Craftmatic/contour Organization, Inc. with the FDA for Mechanical Adjustable Chair (ac Powered).
Device ID | K880861 |
510k Number | K880861 |
Device Name: | MECHANICAL ADJUSTABLE CHAIR (AC POWERED) |
Classification | Chair, Positioning, Electric |
Applicant | CRAFTMATIC/CONTOUR ORGANIZATION, INC. 220 FIFTH AVE. 13TH FLOOR New York, NY 10001 |
Contact | B Chernofsky |
Correspondent | B Chernofsky CRAFTMATIC/CONTOUR ORGANIZATION, INC. 220 FIFTH AVE. 13TH FLOOR New York, NY 10001 |
Product Code | INO |
CFR Regulation Number | 890.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-01 |
Decision Date | 1988-03-17 |