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 syringe, antistick
510(k) Number K070203
Device Name INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024
Applicant
INVIRO MEDICAL DEVICES, INC.
3235 SATELLITE BLVD.
BLDG. 400, STE. 300
DULUTH,  GA  30096
Applicant Contact JIM BARLEY
Correspondent
INVIRO MEDICAL DEVICES, INC.
3235 SATELLITE BLVD.
BLDG. 400, STE. 300
DULUTH,  GA  30096
Correspondent Contact JIM BARLEY
Regulation Number880.5860
Classification Product Code
MEG  
Date Received01/22/2007
Decision Date 04/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-