The following data is part of a premarket notification filed by Skytron, Div. The Kmw Group, Inc. with the FDA for Skytron Life Island 21.
| Device ID | K926045 |
| 510k Number | K926045 |
| Device Name: | SKYTRON LIFE ISLAND 21 |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | SKYTRON, DIV. THE KMW GROUP, INC. 5000 36TH ST., S.E. Grand Rapids, MI 49512 |
| Contact | David M Mehney |
| Correspondent | David M Mehney SKYTRON, DIV. THE KMW GROUP, INC. 5000 36TH ST., S.E. Grand Rapids, MI 49512 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-01 |
| Decision Date | 1993-07-27 |