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 Booth, Sun Tan
510(k) Number K881409
Device Name SUN SHELL (SUN TANNING BED)
Applicant
Indoor Sun Systems, Inc.
2411 Howe Ave.
Sacramento,  CA  95825
Applicant Contact JULIE DEMETROULAS
Correspondent
Indoor Sun Systems, Inc.
2411 Howe Ave.
Sacramento,  CA  95825
Correspondent Contact JULIE DEMETROULAS
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received04/04/1988
Decision Date 04/19/1988
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
Predetermined Change
Control Plan Authorized		 No
-
-