FDA 510(k) Application Details - K961025

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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510(K) Number K961025
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant MEDICINE LODGE, INC.
819 STRIKER AVE., SUITE 10
SACRAMENTO, CA 95834-5432 US
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Contact BRIAN T CLEARY
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Regulation Number 878.5000

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Classification Product Code GAT
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Date Received 03/14/1996
Decision Date 04/15/1996
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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