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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 K180063
Device Name OCM-G1 Attachment
Applicant
The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens,  FL  33410
Applicant Contact Tamara J West
Correspondent
The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens,  FL  33410
Correspondent Contact Tamara J West
Regulation Number874.4250
Classification Product Code
ERL  
Date Received01/09/2018
Decision Date 03/27/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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