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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical
510(k) Number K951811
Device Name OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK
Applicant
Osteotech, Inc.
1151 Shrewsbury Ave.
Shrewsbury,  NJ  07702
Applicant Contact CHRISTOPHER TALBOT
Correspondent
Osteotech, Inc.
1151 Shrewsbury Ave.
Shrewsbury,  NJ  07702
Correspondent Contact CHRISTOPHER TALBOT
Regulation Number878.4800
Classification Product Code
LRP  
Date Received04/19/1995
Decision Date 05/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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