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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 K050247
Device Name CONTOUR NECKLIFT THREADS
Applicant
SURGICAL SPECIALTIES CORP.
100 DENNIS DR.
READING,  PA  19606
Applicant Contact ELIZABETH LAZARO
Correspondent
SURGICAL SPECIALTIES CORP.
100 DENNIS DR.
READING,  PA  19606
Correspondent Contact ELIZABETH LAZARO
Regulation Number878.5010
Classification Product Code
GAW  
Date Received02/02/2005
Decision Date 03/04/2005
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
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