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 K014021
Device Name SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED
Applicant
SURGICAL SPECIALTIES CORP.
100 DENNIS DR.
READING,  PA  19606
Applicant Contact ELIZABETH LAZARO
Correspondent
SURGICAL SPECIALTIES CORP.
100 DENNIS DR.
READING,  PA  19606
Correspondent Contact ELIZABETH LAZARO
Regulation Number878.4493
Classification Product Code
GAM  
Date Received12/06/2001
Decision Date 01/28/2002
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
-
-