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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, Synthetic, Polyethylene
510(k) Number K961025
Device Name EXPANDED BODY SUTURE
Applicant
MEDICINE LODGE, INC.
819 STRIKER AVE., SUITE 10
SACRAMENTO,  CA  95834 -5432
Applicant Contact BRIAN T CLEARY
Correspondent
MEDICINE LODGE, INC.
819 STRIKER AVE., SUITE 10
SACRAMENTO,  CA  95834 -5432
Correspondent Contact BRIAN T CLEARY
Regulation Number878.5000
Classification Product Code
GAT  
Date Received03/14/1996
Decision Date 04/15/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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