• 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 (gastric, colonic, etc.), irrigation and aspiration
510(k) Number K914908
Device Name QUICVAGE PLUS
Applicant
AUTOVAGE
1631 CITATION DR.
SOUTH PARK,  PA  15129
Applicant Contact JOSEPH P RUDOLPH
Correspondent
AUTOVAGE
1631 CITATION DR.
SOUTH PARK,  PA  15129
Correspondent Contact JOSEPH P RUDOLPH
Regulation Number876.5980
Classification Product Code
KDH  
Date Received11/01/1991
Decision Date 04/13/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-