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 Bag, Reservoir
510(k) Number K940220
Device Name REBREATHER BAGS
Applicant
Zefon Medical Products
5350 Southwest First Ln.
Ocala,  FL  34474
Applicant Contact ROBERT L STONE,JR
Correspondent
Zefon Medical Products
5350 Southwest First Ln.
Ocala,  FL  34474
Correspondent Contact ROBERT L STONE,JR
Regulation Number868.5320
Classification Product Code
BTC  
Date Received01/21/1994
Decision Date 05/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-