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 Mouthpiece, Saliva Ejector
510(k) Number K920492
Device Name HIGH VAC
Applicant
Hygoplastic, Inc.
1494 Lakeshore Rd.
Grafton,  WI  53024
Applicant Contact GUNNAR WALLIN
Correspondent
Hygoplastic, Inc.
1494 Lakeshore Rd.
Grafton,  WI  53024
Correspondent Contact GUNNAR WALLIN
Regulation Number872.6640
Classification Product Code
DYN  
Date Received02/03/1992
Decision Date 05/11/1992
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
-
-