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 Condenser, Heat And Moisture (Artificial Nose)
510(k) Number K893875
Device Name FLOCARE
Applicant
MEGA-TECH INTL., INC.
175 STRAFFORD AVE.
WAYNE,  PA  19087
Applicant Contact AL W KRAUS
Correspondent
MEGA-TECH INTL., INC.
175 STRAFFORD AVE.
WAYNE,  PA  19087
Correspondent Contact AL W KRAUS
Regulation Number868.5375
Classification Product Code
BYD  
Date Received05/26/1989
Decision Date 08/11/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-