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FDA 510(k) Application Details - K961025
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
878.5000
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Classification Product Code
GAT
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More FDA Info for this Product Code
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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