FDA 510(k) K141558, QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, by Surgical Specialties Corp
FDA 510(k) K141558, QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, by Surgical Specialties Corp
Device Classification Name: Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number: K141558
Device Name: QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
Applicant: Surgical Specialties Corp
Regulation Number: 878.4493
Classification Product Code: GAM
Date Received: 2014-06-12
Decision Date: 2014-07-11
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: General & Plastic Surgery
Total number of pages: 294
Fully redacted pages: 158
Content pages: 136
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