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 suture, absorbable, synthetic, polyglycolic acid
510(k) Number K023710
Device Name VISORB SWIFT
Applicant
CP MEDICAL
836 N.E. 24TH AVE.
PORTLAND,  OR  97232
Applicant Contact MARY ANN GREENAWALT
Correspondent
CP MEDICAL
836 N.E. 24TH AVE.
PORTLAND,  OR  97232
Correspondent Contact MARY ANN GREENAWALT
Regulation Number878.4493
Classification Product Code
GAM  
Date Received11/04/2002
Decision Date 01/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-