• 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 K872917
Device Name JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER
Applicant
AMERICAN PHARMASEAL DIV. AHSC
27200 NORTH TOURNEY RD.
POST OFFICE BOX 5900
VALENCIA,  CA  91355
Applicant Contact ROBERT T MERRICK
Correspondent
AMERICAN PHARMASEAL DIV. AHSC
27200 NORTH TOURNEY RD.
POST OFFICE BOX 5900
VALENCIA,  CA  91355
Correspondent Contact ROBERT T MERRICK
Regulation Number868.6810
Classification Product Code
BSY  
Date Received07/27/1987
Decision Date 08/11/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-