FDA Import Refusal 799-9328465-0/11/1 — ESTABLISMENT LABS S.A.

ESTABLISMENT LABS S.A. — FEI 3014311077

The FDA refused shipment 799-9328465-0/11/1 from ESTABLISMENT LABS S.A. (Costa Rica) on Nov 18, 2020. The refused product falls under Devices — PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED. Cited charges: 118,237,3280

Refusal details

Date
Nov 18, 2020
Country
Costa Rica
Product Category
Devices
Product Code
79FTR PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
Charges
118,237,3280

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.