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 mouthpiece, breathing
510(k) Number K955657
Device Name NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
Applicant
NORTH STATE PLASTICS, INC.
12850 EAST 40TH AVE., SUITE 98
DENVER,  CO  80239
Applicant Contact ALEX MCKINNON
Correspondent
NORTH STATE PLASTICS, INC.
12850 EAST 40TH AVE., SUITE 98
DENVER,  CO  80239
Correspondent Contact ALEX MCKINNON
Regulation Number868.5620
Classification Product Code
BYP  
Date Received12/12/1995
Decision Date 03/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-