• 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 K842198
Device Name AMER. PHARMASEAL NO TOUCH SATIN CATHET
Applicant
AMERICAN PHARMASEAL DIV. AHSC
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN PHARMASEAL DIV. AHSC
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.6810
Classification Product Code
BSY  
Date Received06/04/1984
Decision Date 06/25/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-