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 Catheters, Suction, Tracheobronchial
510(k) Number K960488
Device Name NEO 2 LINE SUCTION SYSTEM
Applicant
Alcove Medical, Inc.
803 N. 300 W., #405
Salt Lake City,  UT  84103
Applicant Contact CARY P JENKINS
Correspondent
Alcove Medical, Inc.
803 N. 300 W., #405
Salt Lake City,  UT  84103
Correspondent Contact CARY P JENKINS
Regulation Number868.6810
Classification Product Code
BSY  
Date Received02/01/1996
Decision Date 04/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-