• 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 K945266
Device Name OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES
Applicant
OPTUS, INC.
1200 SOUTH PARKER RD.
DENVER,  CO  80231
Applicant Contact PETER DUFFY
Correspondent
OPTUS, INC.
1200 SOUTH PARKER RD.
DENVER,  CO  80231
Correspondent Contact PETER DUFFY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/28/1994
Decision Date 02/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-