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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Manual Surgical Instrument
510(k) Number K934260
Device Name BARRIER BONE WAX APPLICATOR
Applicant
Phillips Pharmaceuticals, Inc.
710 E. Ogden Ave.
Suite 207
Naperville,  IL  60563
Applicant Contact A.G. PHILLIPS
Correspondent
Phillips Pharmaceuticals, Inc.
710 E. Ogden Ave.
Suite 207
Naperville,  IL  60563
Correspondent Contact A.G. PHILLIPS
Regulation Number888.4540
Classification Product Code
LXH  
Date Received08/31/1993
Decision Date 01/26/1994
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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