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 Tracheostomy And Nasal Suctioning Kit
510(k) Number K950851
Device Name GENT-L-KARE TRACHEOSTOMY TRAYS
Applicant
Premium Plastics, Inc.
465 W. Cermak Rd.
Chicago,  IL  60616
Applicant Contact GARY GARBIN
Correspondent
Premium Plastics, Inc.
465 W. Cermak Rd.
Chicago,  IL  60616
Correspondent Contact GARY GARBIN
Classification Product Code
LRQ  
Date Received02/24/1995
Decision Date 06/21/1995
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-