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
510(k) Number K003015
Device Name SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
Applicant
SURGICAL SPECIALTIES CORP.
100 DENNIS DR.
READING,  PA  19606
Applicant Contact VIKKI M HOFFMAN
Correspondent
SURGICAL SPECIALTIES CORP.
100 DENNIS DR.
READING,  PA  19606
Correspondent Contact VIKKI M HOFFMAN
Regulation Number878.4830
Classification Product Code
GAN  
Date Received09/27/2000
Decision Date 12/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-