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 Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(k) Number K895357
Device Name ANETHESIA BREATHING CIRCUIT
Applicant
F.L.W. PLASTICS, INC.
4920 N. WARREN DR.
COLUMBUS,  IN  47203
Applicant Contact TIMOTHY D STRUTHERS
Correspondent
F.L.W. PLASTICS, INC.
4920 N. WARREN DR.
COLUMBUS,  IN  47203
Correspondent Contact TIMOTHY D STRUTHERS
Regulation Number868.5240
Classification Product Code
CAI  
Date Received08/28/1989
Decision Date 10/19/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-