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 K932553
Device Name DISPOSABLE SUTURE PLACEMENT SYSTEM
Applicant
Laurus Medical Corp.
30 Hughes
Suite 202
Irvine,  CA  92718
Applicant Contact NORMAN GORDON
Correspondent
Laurus Medical Corp.
30 Hughes
Suite 202
Irvine,  CA  92718
Correspondent Contact NORMAN GORDON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/26/1993
Decision Date 05/12/1994
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-