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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Marrow Collection/Transfusion Kit
510(k) Number K952350
Device Name JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)
Applicant
Promedical , Ltd.
240 Braen Ave.
Wyckoff,  NJ  07481
Applicant Contact HENRY V SIERAKOWSKI
Correspondent
Promedical , Ltd.
240 Braen Ave.
Wyckoff,  NJ  07481
Correspondent Contact HENRY V SIERAKOWSKI
Classification Product Code
LWE  
Date Received05/19/1995
Decision Date 07/17/1995
Decision Substantially Equivalent (SESE)
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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