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 Nebulizer (Direct Patient Interface)
510(k) Number K963917
Device Name HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT
Applicant
Holden Walker Corp.
4227 B Arnold Ave.
P.O. Box 8207
Naples,  FL  33941 -8207
Applicant Contact DONALD L RETALLICK, III
Correspondent
Holden Walker Corp.
4227 B Arnold Ave.
P.O. Box 8207
Naples,  FL  33941 -8207
Correspondent Contact DONALD L RETALLICK, III
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/30/1996
Decision Date 02/25/1997
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-