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 Mask, Oxygen
510(k) Number K913455
Device Name OXYGEN MASKS 82400 & 82405
Applicant
SPECIALTY PACKAGING PRODUCS, INC.
19 LEIGH FISHER
EL PASO,  TX  79906
Applicant Contact EDWARD F VALDEZ
Correspondent
SPECIALTY PACKAGING PRODUCS, INC.
19 LEIGH FISHER
EL PASO,  TX  79906
Correspondent Contact EDWARD F VALDEZ
Regulation Number868.5580
Classification Product Code
BYG  
Date Received08/02/1991
Decision Date 10/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-