• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name pillow, cervical (for mild sleep apnea)
510(k) Number K100160
Device Name ZZOMA POSITIONAL SLEEPER MODEL 001
Applicant
SLEEP SPECIALISTS, LLC
1 CONGRESSIONAL DRIVE
APT C
greenville,  DE  19807
Applicant Contact howard mann
Correspondent
SLEEP SPECIALISTS, LLC
1 CONGRESSIONAL DRIVE
APT C
greenville,  DE  19807
Correspondent Contact howard mann
Regulation Number872.5570
Classification Product Code
MYB  
Date Received01/20/2010
Decision Date 05/11/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-