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, Water, Temperature Regulated
510(k) Number K812682
Device Name FLEXFLOAT HEATER
Applicant
PHARMAQUEST CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PHARMAQUEST CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5560
Classification Product Code
FOH  
Date Received09/22/1981
Decision Date 10/08/1981
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
-
-