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 Catheter And Tip, Suction
510(k) Number K974758
Device Name HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
Applicant
Hydrox Laboratories
825 B Tollgate Rd.
Elgin,  IL  60123
Applicant Contact KAPPANA RAMANANDAN
Correspondent
Hydrox Laboratories
825 B Tollgate Rd.
Elgin,  IL  60123
Correspondent Contact KAPPANA RAMANANDAN
Regulation Number880.6740
Classification Product Code
JOL  
Date Received12/19/1997
Decision Date 03/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-