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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, Polypropylene
510(k) Number K021834
Device Name SUTURE FIXATION DEVICE; MESH FIXATION DEVICE
Applicant
Mle, Inc.
10 Greenlawn Ave.
South Grafton,  MA  01560
Applicant Contact CHRISTINE E NICHOLS
Correspondent
Mle, Inc.
10 Greenlawn Ave.
South Grafton,  MA  01560
Correspondent Contact CHRISTINE E NICHOLS
Regulation Number878.5010
Classification Product Code
GAW  
Date Received06/04/2002
Decision Date 08/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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