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 Aligner, Bracket, Orthodontic
510(k) Number K851454
Device Name A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS
Applicant
A Company, Inc.
11436 Sorrento Valley Rd.
Post Office Box 81247
San Diego,  CA  92138
Applicant Contact JOE MONFREDO
Correspondent
A Company, Inc.
11436 Sorrento Valley Rd.
Post Office Box 81247
San Diego,  CA  92138
Correspondent Contact JOE MONFREDO
Regulation Number872.4565
Classification Product Code
ECQ  
Date Received04/11/1985
Decision Date 04/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-