• 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 hearing aid, air-conduction, prescription
510(k) Number K881480
Device Name FIRST AMERICAN, RADIONIC, JKR, MODEL AC
Applicant
JKR LABORATORIES, INC.
10701 WEST KELLOGG
P.O. BOX 12201
WICHITA,  KS  67209
Applicant Contact JERRY BLUE
Correspondent
JKR LABORATORIES, INC.
10701 WEST KELLOGG
P.O. BOX 12201
WICHITA,  KS  67209
Correspondent Contact JERRY BLUE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/05/1988
Decision Date 08/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-