The following data is part of a premarket notification filed by Skytron, Div. The Kmw Group, Inc. with the FDA for Skytron Elite 3100 Surgical Table.
Device ID | K851829 |
510k Number | K851829 |
Device Name: | SKYTRON ELITE 3100 SURGICAL TABLE |
Classification | Table, Operating-room, Electrical |
Applicant | SKYTRON, DIV. THE KMW GROUP, INC. 5000 36TH ST., S.E. Grand Rapids, MI 49512 |
Contact | Larry J Purcey |
Correspondent | Larry J Purcey SKYTRON, DIV. THE KMW GROUP, INC. 5000 36TH ST., S.E. Grand Rapids, MI 49512 |
Product Code | GDC |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-26 |
Decision Date | 1985-05-17 |