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 Device, Thermal, Hemorrhoids
510(k) Number K854569
Device Name HEMOR-ICE
Applicant
Technology 2000
325 Tenth St.
Lakewood,  NJ  08701
Correspondent
Technology 2000
325 Tenth St.
Lakewood,  NJ  08701
Classification Product Code
LKX  
Date Received11/14/1985
Decision Date 02/05/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-