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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, absorbable, synthetic, polyglycolic acid
510(K) Number K122898
Model VLM-1001
Device Name QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
Applicant
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
100 dennis dr.
reading,  PA  19606
Contact kirsten stowell
Regulation Number878.4493
Classification Product Code
GAM  
Date Received09/21/2012
Decision Date 10/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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