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, Urological
510(k) Number K951260
Device Name URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT
Applicant
Biosearch Medical Products, Inc.
35 Industrial Pkwy.
P.O. Box 1700
Somerville,  NJ  08876
Applicant Contact MARTIN DYCK
Correspondent
Biosearch Medical Products, Inc.
35 Industrial Pkwy.
P.O. Box 1700
Somerville,  NJ  08876
Correspondent Contact MARTIN DYCK
Regulation Number876.5130
Classification Product Code
KOD  
Date Received03/21/1995
Decision Date 09/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-