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 Laparoscope, General & Plastic Surgery
510(k) Number K033842
Device Name NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE
Applicant
VERNON-CARUS LIMITED
PO BOX 2608
MORGAN HILL,  CA  95038
Applicant Contact C. ROBERT PAYNE, JR., P.E.
Correspondent
VERNON-CARUS LIMITED
PO BOX 2608
MORGAN HILL,  CA  95038
Correspondent Contact C. ROBERT PAYNE, JR., P.E.
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/10/2003
Decision Date 03/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-