The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Nagashima Sn Operator's Chair.
Device ID | K822264 |
510k Number | K822264 |
Device Name: | NAGASHIMA SN OPERATOR'S CHAIR |
Classification | Chair, Surgical, Ac-powered |
Applicant | KELLEHER CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GBB |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-29 |
Decision Date | 1982-10-13 |