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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media And Components, Synthetic Cell And Tissue Culture
510(k) Number K883065
Device Name ALLOPREP SYSTEM
Applicant
Osteotech, Inc.
1151 E Sherewsbury Ave.
Shrewsbury,  NJ  07702
Applicant Contact CHEN, PHD
Correspondent
Osteotech, Inc.
1151 E Sherewsbury Ave.
Shrewsbury,  NJ  07702
Correspondent Contact CHEN, PHD
Regulation Number864.2220
Classification Product Code
KIT  
Date Received07/20/1988
Decision Date 10/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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