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- Sat Aug 09, 2008 7:33 am
- Forum: CPAP and Sleep Apnea Message Board
- Topic: Soyala Nasal Mask Issue
- Replies: 13
- Views: 2424
I hadn't heard about the gel cushions. But as a new release, the odds are strong that it will come with the new HEADstrap headgear. I did find application to the FDA for the 'Soyala GEL' which weinmann applied for on 4/8/08, and FDA approval granted on May 9,08. http://www.fda.gov/cdrh/pdf8/K081014....