510(k) K905285
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