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FDA 510(k) Application Details - K001434
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
More FDA Info for this Device
510(K) Number
K001434
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
600 AIRPORT RD.
FALL RIVER, MA 02720-4740 US
Other 510(k) Applications for this Company
Contact
MARY E GRAY
Other 510(k) Applications for this Contact
Regulation Number
878.5000
More FDA Info for this Regulation Number
Classification Product Code
GAT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/08/2000
Decision Date
06/12/2000
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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