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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 K895587
Device Name CROSS MEDICAL PRODUCT PEDICLE AWL
Applicant
Cross Medical Products, Inc.
921 Calle Verde
Martinez,  CA  94553
Applicant Contact BROMM, R.N.
Correspondent
Cross Medical Products, Inc.
921 Calle Verde
Martinez,  CA  94553
Correspondent Contact BROMM, R.N.
Regulation Number888.4540
Classification Product Code
HWJ  
Date Received09/15/1989
Decision Date 01/04/1990
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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