• 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 System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K961029
Device Name KILTEX PROBE COVER
Applicant
KILTEX CORP.
2064 KILLIAN RD.
AKRON,  OH  44312
Applicant Contact TIMOTHY J KILLIAN
Correspondent
KILTEX CORP.
2064 KILLIAN RD.
AKRON,  OH  44312
Correspondent Contact TIMOTHY J KILLIAN
Regulation Number892.1560
Classification Product Code
IYO  
Date Received03/14/1996
Decision Date 07/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-