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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Pressure, Intracompartmental
510(k) Number K873684
Device Name ACE INTRA COMPARTMENTAL PRESSURE MONITOR
Applicant
Ace Medical Co.
David W. Schlerf
921 Calle Verde
Martinez,  CA  94553
Applicant Contact DAVID SCHLERF
Correspondent
Ace Medical Co.
David W. Schlerf
921 Calle Verde
Martinez,  CA  94553
Correspondent Contact DAVID SCHLERF
Classification Product Code
LXC  
Date Received09/14/1987
Decision Date 01/20/1988
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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