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 K925015
Device Name STERILE SUTURE REMOVAL KIT
Applicant
Customed, Inc.
Calle Igualdad #7
Fajardo,  PR  00738
Applicant Contact FELIX B SANTOS
Correspondent
Customed, Inc.
Calle Igualdad #7
Fajardo,  PR  00738
Correspondent Contact FELIX B SANTOS
Regulation Number878.4800
Classification Product Code
MCZ  
Date Received09/24/1992
Decision Date 06/07/1993
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
Recalls CDRH Recalls
-
-