510(k) K905285

IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES by Internacional Farmaceutica, S.A. DE C.V. — Product Code GAS

K905285 is an FDA 510(k) premarket notification submitted by Internacional Farmaceutica, S.A. DE C.V. for the device "IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES". The FDA issued a decision of Substantially Equivalent on February 11, 1991. The device falls under product code GAS (Suture, Nonabsorbable, Synthetic, Polyester), a Class II device regulated under 21 CFR 878.5000. Internacional Farmaceutica, S.A. DE C.V. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1991
Date Received
November 26, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyester
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type