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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trephine
510(k) Number K851339
Device Name PRECISION HARVEST & INLAY INSTRUMENT SET
Applicant
Concept, Inc.
12707 U.S. 19 S.
Clearwater,  FL  33546
Applicant Contact PENNY C RASMUSSEN
Correspondent
Concept, Inc.
12707 U.S. 19 S.
Clearwater,  FL  33546
Correspondent Contact PENNY C RASMUSSEN
Regulation Number888.4540
Classification Product Code
HWK  
Date Received04/03/1985
Decision Date 07/02/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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