The following data is part of a premarket notification filed by Skytron, Div. The Kmw Group, Inc. with the FDA for Skytron Elite 3500 Table.
| Device ID | K940616 |
| 510k Number | K940616 |
| Device Name: | SKYTRON ELITE 3500 TABLE |
| Classification | Table, Operating-room, Electrical |
| Applicant | SKYTRON, DIV. THE KMW GROUP, INC. 5000 36TH ST S.E. P.O.BOX 888615 Grand Rapids, MI 49588 -8615 |
| Contact | David M Mehney |
| Correspondent | David M Mehney SKYTRON, DIV. THE KMW GROUP, INC. 5000 36TH ST S.E. P.O.BOX 888615 Grand Rapids, MI 49588 -8615 |
| Product Code | GDC |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-14 |
| Decision Date | 1994-06-13 |