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 Mattress, Air Flotation, Alternating Pressure
510(k) Number K953675
Device Name ALTADYNE
Applicant
Lumex, Inc.
100 Spence St.
Bay Shore,  NY  11706 -2290
Applicant Contact JAMES TERRACCIANO
Correspondent
Lumex, Inc.
100 Spence St.
Bay Shore,  NY  11706 -2290
Correspondent Contact JAMES TERRACCIANO
Regulation Number880.5550
Classification Product Code
FNM  
Date Received08/07/1995
Decision Date 09/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-