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 Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K972057
Device Name POWERTREK INSTRUMENTS
Applicant
MEDTREK CORP.
1204 MAIN ST., SUITE 224
BRANFORD,  CT  06405
Applicant Contact DOM L GATTO
Correspondent
MEDTREK CORP.
1204 MAIN ST., SUITE 224
BRANFORD,  CT  06405
Correspondent Contact DOM L GATTO
Regulation Number874.4250
Classification Product Code
ERL  
Subsequent Product Code
HRX  
Date Received06/02/1997
Decision Date 11/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-