The following data is part of a premarket notification filed by Lumex, Inc. with the FDA for Altadyne.
| Device ID | K953675 |
| 510k Number | K953675 |
| Device Name: | ALTADYNE |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | LUMEX, INC. 100 SPENCE ST. Bay Shore, NY 11706 -2290 |
| Contact | James Terracciano |
| Correspondent | James Terracciano LUMEX, INC. 100 SPENCE ST. Bay Shore, NY 11706 -2290 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-07 |
| Decision Date | 1995-09-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ALTADYNE 74641131 2032814 Dead/Cancelled |
GF HEALTH PRODUCTS, INC. 1995-03-02 |