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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
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