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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cerclage, fixation
510(k) Number K000694
Device Name PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)
Applicant
PECTOFIX, INC.
481 MEMORIAL PKWY.
METUCHEN,  NJ  08840
Applicant Contact ERIC BANNON
Correspondent
PECTOFIX, INC.
481 MEMORIAL PKWY.
METUCHEN,  NJ  08840
Correspondent Contact ERIC BANNON
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received03/01/2000
Decision Date 05/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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