The following data is part of a premarket notification filed by Dermalex Co. with the FDA for Pegasus Mattress.
Device ID | K833964 |
510k Number | K833964 |
Device Name: | PEGASUS MATTRESS |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | DERMALEX CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-16 |
Decision Date | 1984-01-30 |