Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Cushion, Flotation
510(k) Number K911843
Device Name ZERO-G(TM) GEL/FOAM MATTRESS TOPPER
Applicant
Steridyne Corp.
3725 Investment Ln.
Riviera Beach,  FL  33404
Applicant Contact MARK P PONCY
Correspondent
Steridyne Corp.
3725 Investment Ln.
Riviera Beach,  FL  33404
Correspondent Contact MARK P PONCY
Regulation Number890.3175
Classification Product Code
KIC  
Date Received04/25/1991
Decision Date 05/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-