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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, surgical, orthopedic, pneumatic powered & accessory/attachment
510(k) Number K864314
Device Name EFTEKHAR RECHANNELIZATION DRILL GUIDE
Applicant
THE ANSPACH EFFORT, INC.
1349 S. KILLIAN DR.
LAKE PARK,  FL  33403
Applicant Contact ANSPACH, JR.
Correspondent
THE ANSPACH EFFORT, INC.
1349 S. KILLIAN DR.
LAKE PARK,  FL  33403
Correspondent Contact ANSPACH, JR.
Regulation Number878.4820
Classification Product Code
HSZ  
Date Received11/03/1986
Decision Date 11/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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