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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable
510(k) Number K932513
Device Name LABELING FOR MYO/WIRE II STERNOTOMY SUTURES
Applicant
ALTO DEVELOPMENT CORP.
5012 ASBURY RD.
P.O. BOX 758
FARMINGDALE,  NJ  07727
Applicant Contact TIM WOJCIECHOWICZ
Correspondent
ALTO DEVELOPMENT CORP.
5012 ASBURY RD.
P.O. BOX 758
FARMINGDALE,  NJ  07727
Correspondent Contact TIM WOJCIECHOWICZ
Regulation Number878.4495
Classification Product Code
GAO  
Date Received05/25/1993
Decision Date 01/07/1994
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
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