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 Otoscope
510(k) Number K941659
Device Name AURAL-CAM, VIDEO EAR, VID RX
Applicant
GRACEFULLY YOURS, INC.
12527 ULMERTON RD.
LARGO,  FL  34644
Applicant Contact RONALD A PRIEST
Correspondent
GRACEFULLY YOURS, INC.
12527 ULMERTON RD.
LARGO,  FL  34644
Correspondent Contact RONALD A PRIEST
Regulation Number874.4770
Classification Product Code
ERA  
Date Received04/05/1994
Decision Date 04/26/1994
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
-
-