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 Chamber, Patient Isolation
510(k) Number K864116
Device Name ANAGO ISOLATION MASK (#80-950)
Applicant
Anago, Inc.
7524 Mosier View Ct.
Fort Worth,  TX  76118
Applicant Contact KATHY RUSSELL
Correspondent
Anago, Inc.
7524 Mosier View Ct.
Fort Worth,  TX  76118
Correspondent Contact KATHY RUSSELL
Regulation Number880.5450
Classification Product Code
LGM  
Date Received10/21/1986
Decision Date 11/25/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-