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 Unit, Examining/Treatment, Ent
510(k) Number K945395
Device Name PREMIER MIRROR WARMER
Applicant
PREMIER DENTAL PRODUCTS CO.
10090 SANDMEYER LN.
PHILADELPHIA,  PA  19116 -3502
Applicant Contact WILLIAM J FREZEL
Correspondent
PREMIER DENTAL PRODUCTS CO.
10090 SANDMEYER LN.
PHILADELPHIA,  PA  19116 -3502
Correspondent Contact WILLIAM J FREZEL
Regulation Number874.5300
Classification Product Code
ETF  
Date Received11/03/1994
Decision Date 01/18/1995
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
-
-