Shandong Blue Sail Innovation Co Ltd
WEIFANG Shandong, CN
SHANDONG BLUE SAIL INNOVATION CO LTD appears in FDA device records in WEIFANG Shandong, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Shandong Blue Sail Innovation Co Ltd between 2010 and 2011. The busiest year on record is 2010, with 2. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 2 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103619 | SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED) | LYZ | Substantially Equivalent | |
| K102161 | BLUE SAIL INNOVATION | LYZ | Substantially Equivalent | |
| K102160 | STRETCH VINYL EXAMINATION GLOVE POWDER FREE | LYZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004150701 | 3004150701 | SHANDONG BLUE SAIL INNOVATION CO LTD | East Side of Xingan Road,, WEIFANG Shandong 262600 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain