• 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 Light, Ultraviolet, Dermatological
510(k) Number K851858
Device Name FOLD AWAY HUT
Applicant
TANNHUT
ROUTE 50
SARATOGA SPRINGS,  NY  12866
Applicant Contact JANICE SHIVETTS
Correspondent
TANNHUT
ROUTE 50
SARATOGA SPRINGS,  NY  12866
Correspondent Contact JANICE SHIVETTS
Regulation Number878.4630
Classification Product Code
FTC  
Date Received04/26/1985
Decision Date 05/14/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-