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, Incontinence, Urosheath Type, Sterile
510(k) Number K952082
Device Name ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER
Applicant
Rochester Medical Corp.
1500 2nd Ave. Northwest
Stewartville,  MN  55976
Applicant Contact RICHARD D FRYAR
Correspondent
Rochester Medical Corp.
1500 2nd Ave. Northwest
Stewartville,  MN  55976
Correspondent Contact RICHARD D FRYAR
Regulation Number876.5250
Classification Product Code
EXJ  
Date Received05/03/1995
Decision Date 07/18/1995
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
-
-