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 Device, Anti-Snoring
510(k) Number K955822
Device Name REMOVABLE HERBST APPLIANCE
Applicant
UNIV. DENTAL ASSOC. DEPARTMENT OF ORTHODONTICS
140 SQUIRE HALL
BUFFALO,  NY  14214
Applicant Contact STEPHEN P WARUNEK
Correspondent
UNIV. DENTAL ASSOC. DEPARTMENT OF ORTHODONTICS
140 SQUIRE HALL
BUFFALO,  NY  14214
Correspondent Contact STEPHEN P WARUNEK
Regulation Number872.5570
Classification Product Code
LRK  
Date Received12/26/1995
Decision Date 03/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-