FDA Import Refusal 98K-2253871-6/10002/1 — Planet Innovation Pty Ltd
The FDA refused shipment 98K-2253871-6/10002/1 from Planet Innovation Pty Ltd (Australia) on June 10, 2026. The refused product falls under Devices — POWERED MICRONEEDLE DEVICE. Cited charges: 118,3280,3904,3905,508
Refusal Details
- Date
- June 10, 2026
- Country
- Australia
- Product Category
- Devices
- Product Code
- 79QAI POWERED MICRONEEDLE DEVICE
- Charges
- 118,3280,3904,3905,508