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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 K944476
Device Name APEX UNIVERSAL DRIVE SYSTEM
Applicant
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773
Applicant Contact CAROL A WEIDEMAN
Correspondent
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773
Correspondent Contact CAROL A WEIDEMAN
Regulation Number874.4250
Classification Product Code
ERL  
Date Received09/12/1994
Decision Date 11/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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