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 K915306
Device Name THE KAUFMANN LIFT-AND-TURN MATTRESS
Applicant
KAUFMANN SJUKVARDSARTIKLAR
C/O SWEDISH TRADE COUNCIL
150 N. MICHIGAN AVE., STE 1200
CHICAGO,  IL  60601
Applicant Contact SVEN E SIEVERS
Correspondent
KAUFMANN SJUKVARDSARTIKLAR
C/O SWEDISH TRADE COUNCIL
150 N. MICHIGAN AVE., STE 1200
CHICAGO,  IL  60601
Correspondent Contact SVEN E SIEVERS
Regulation Number880.5550
Classification Product Code
FNM  
Date Received11/21/1991
Decision Date 01/27/1993
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
-
-