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 Paper, Articulation
510(k) Number K911259
Device Name HYDENT
Applicant
Pascal Co., Inc.
P.O. Box 1478
Bellevue,  WA  98009
Applicant Contact JOE PELLICANO
Correspondent
Pascal Co., Inc.
P.O. Box 1478
Bellevue,  WA  98009
Correspondent Contact JOE PELLICANO
Regulation Number872.6140
Classification Product Code
EFH  
Date Received03/22/1991
Decision Date 06/06/1991
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
-
-