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 Bath, Hydro-Massage
510(k) Number K911758
Device Name AMISH COUNTRY SPA
Applicant
Fox Pool Corp.
C/O Law Offices Morris/Vedder
32 N. Duke St.
York,  PA  17405
Applicant Contact MICHAEL J KROUT
Correspondent
Fox Pool Corp.
C/O Law Offices Morris/Vedder
32 N. Duke St.
York,  PA  17405
Correspondent Contact MICHAEL J KROUT
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received04/18/1991
Decision Date 10/02/1991
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
-
-