The following data is part of a premarket notification filed by Cherne Industries, Inc. with the FDA for Adec 1005-c Chair.
Device ID | K864072 |
510k Number | K864072 |
Device Name: | ADEC 1005-C CHAIR |
Classification | Table, Examination, Medical, Powered |
Applicant | CHERNE INDUSTRIES, INC. 5701 SOUTH COUNTY RD. 18 Minneapolis, MN 55436 |
Contact | Mark W Kroll |
Correspondent | Mark W Kroll CHERNE INDUSTRIES, INC. 5701 SOUTH COUNTY RD. 18 Minneapolis, MN 55436 |
Product Code | LGX |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-20 |
Decision Date | 1986-11-07 |