• 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, Oxygen, Topical, Extremity
510(k) Number K883848
Device Name KMI OXY-BAN
Applicant
KNIGHT MEDICAL, INC.
18120 AMMI TRAIL
HOUSTON,  TX  77060
Applicant Contact KENNETH E CLARY
Correspondent
KNIGHT MEDICAL, INC.
18120 AMMI TRAIL
HOUSTON,  TX  77060
Correspondent Contact KENNETH E CLARY
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received09/12/1988
Decision Date 03/02/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-