FDA 510(k) Application Details - K003015

Device Classification Name Suture, Absorbable, Synthetic

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510(K) Number K003015
Device Name Suture, Absorbable, Synthetic
Applicant SURGICAL SPECIALTIES CORP.
100 DENNIS DR.
READING, PA 19606 US
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Contact VIKKI M HOFFMAN
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Regulation Number 878.4830

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Classification Product Code GAN
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Date Received 09/27/2000
Decision Date 12/15/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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