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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 K131053
Device Name ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
Applicant
The Anspach Effort, Inc.
3012 St. Charles Dr.
Tampa,  FL  33618
Applicant Contact ANNETTE M HILLRING
Correspondent
The Anspach Effort, Inc.
3012 St. Charles Dr.
Tampa,  FL  33618
Correspondent Contact ANNETTE M HILLRING
Regulation Number874.4250
Classification Product Code
ERL  
Subsequent Product Code
EQJ  
Date Received04/16/2013
Decision Date 12/31/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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