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 Cover, Barrier, Protective
510(k) Number K023540
Device Name SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09
Applicant
Valumed
1439 Live Oak St.
Suite A
Niceville,  FL  32578
Applicant Contact THOMAS E COTTONE
Correspondent
Valumed
1439 Live Oak St.
Suite A
Niceville,  FL  32578
Correspondent Contact THOMAS E COTTONE
Regulation Number878.4370
Classification Product Code
MMP  
Date Received10/22/2002
Decision Date 02/04/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-