The following data is part of a premarket notification filed by Skytron, Div. The Kmw Group, Inc. with the FDA for Skytron Model 1100 And Model 142.
Device ID | K900290 |
510k Number | K900290 |
Device Name: | SKYTRON MODEL 1100 AND MODEL 142 |
Classification | Table, Surgical With Orthopedic Accessories, Ac-powered |
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 | JEA |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-22 |
Decision Date | 1990-02-20 |