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 Hood, Oxygen, Infant
510(k) Number K962182
Device Name BURLEW INFANT HOOD
Applicant
Promedic, Inc.
6329 W.Waterview Ct.
Mccordsville,  IN  46055 -9501
Applicant Contact PAUL E DRYDEN
Correspondent
Promedic, Inc.
6329 W.Waterview Ct.
Mccordsville,  IN  46055 -9501
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5700
Classification Product Code
FOG  
Date Received06/06/1996
Decision Date 07/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-