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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 K003951
Device Name PECTOFIX STERNAL REPAIR WIRE
Applicant
Pectofix, Inc.
2509 Park Ave.
South Plainfield,  NJ  07080
Applicant Contact ERIC BANNON
Correspondent
Pectofix, Inc.
2509 Park Ave.
South Plainfield,  NJ  07080
Correspondent Contact ERIC BANNON
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received12/21/2000
Decision Date 03/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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