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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Awl
510(k) Number K875223
Device Name DANNINGER ORTHOPAEDIC AWL
Applicant
Danninger Medical Technology, Inc.
C/O Buckman Co.Inc.
1000 Burnett Ave.Suite 250
Concord,  CA  94520
Applicant Contact DAVID SCHLERF
Correspondent
Danninger Medical Technology, Inc.
C/O Buckman Co.Inc.
1000 Burnett Ave.Suite 250
Concord,  CA  94520
Correspondent Contact DAVID SCHLERF
Regulation Number888.4540
Classification Product Code
HWJ  
Date Received12/22/1987
Decision Date 02/17/1988
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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