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 Removal Kit
510(k) Number K943046
Device Name SKIN STAPLE REMOVAL TRAYS
Applicant
Sterile Concepts, Inc.
5100 Commerce Rd..
Richmond,  VA  23234
Applicant Contact KAY ANDREWS
Correspondent
Sterile Concepts, Inc.
5100 Commerce Rd..
Richmond,  VA  23234
Correspondent Contact KAY ANDREWS
Regulation Number878.4800
Classification Product Code
MCZ  
Date Received06/27/1994
Decision Date 07/29/1994
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-