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 Surgical Instruments, G-U, Manual (And Accessories)
510(k) Number K841003
Device Name PROBES, VARIOUS
Applicant
Premier Dental Products Co.
1710 Romano Dr.
P.O. Box 111
Norristown,  PA  19401
Applicant Contact WILLIAM J FREZEL
Correspondent
Premier Dental Products Co.
1710 Romano Dr.
P.O. Box 111
Norristown,  PA  19401
Correspondent Contact WILLIAM J FREZEL
Regulation Number876.4730
Classification Product Code
KOA  
Date Received03/09/1984
Decision Date 03/20/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-