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 K971593
Device Name SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT
Applicant
The Silcraft Corp.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Applicant Contact HOWARD M HOLSTEIN
Correspondent
The Silcraft Corp.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received05/01/1997
Decision Date 02/26/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-