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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement Obturator
510(k) Number K943727
Device Name BIOSTOP G BONE CEMENT RESTRICTOR
Applicant
LANDOS, INC.
STE 1, 301 LINDENWOOD DR.
OFFICE 26
MALVERN,  PA  19355
Applicant Contact JEROME VERON
Correspondent
LANDOS, INC.
STE 1, 301 LINDENWOOD DR.
OFFICE 26
MALVERN,  PA  19355
Correspondent Contact JEROME VERON
Regulation Number878.3300
Classification Product Code
LZN  
Subsequent Product Code
JDK  
Date Received08/02/1994
Decision Date 05/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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