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 Tubes, Gastrointestinal (And Accessories)
510(k) Number K864218
FOIA Releasable 510(k) K864218
Device Name PROCON
Applicant
HEALTHCARE MANAGEMENT SYSTEMS
3160 N. TRACKEE LN. #22
SPARKS,  NV  89431
Applicant Contact MICHAEL E FISHER
Correspondent
HEALTHCARE MANAGEMENT SYSTEMS
3160 N. TRACKEE LN. #22
SPARKS,  NV  89431
Correspondent Contact MICHAEL E FISHER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/28/1986
Decision Date 01/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-