ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID— 510(k) K040282
Substantially EquivalentInternacional Farmaceutica, S.A. DE C.V.
FDA 510(k) clearance K040282 for ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID, Substantially Equivalent on 2004-04-29. Applicant: Internacional Farmaceutica, S.A. DE C.V.. Device class: 2.
Clearance details
- Applicant
- Internacional Farmaceutica, S.A. DE C.V.
- Product code
- Code GAM
- Device class
- Class 2
- Regulation
- 21 CFR 878.4493
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, US
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More clearances from Internacional Farmaceutica, S.A. DE C.V.
view all- K072859 — ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES
- K072863 — ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES
- K041048 — POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K913185 — STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT
- K911354 — STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES
Adverse events under product code GAM
product code GAM- Death
- 45
- Injury
- 5,711
- Malfunction
- 30,744
- Other
- 4
- Total
- 36,504
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.