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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 K972865
Device Name PROMEX ENT TISSUE REMOVAL SYSTEM
Applicant
PROMEX, INC.
1125 BROOKSIDE AVE.
SUITE G500
INDIANAPOLIS,  IN  46202
Applicant Contact JOSEPH L MARK
Correspondent
PROMEX, INC.
1125 BROOKSIDE AVE.
SUITE G500
INDIANAPOLIS,  IN  46202
Correspondent Contact JOSEPH L MARK
Regulation Number874.4250
Classification Product Code
ERL  
Date Received08/04/1997
Decision Date 09/29/1997
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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