510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Shu Gie Industrial Co., Ltd.

Tainan City, TW

SHU GIE INDUSTRIAL CO., LTD. appears in FDA device records in Tainan City, TW. FDA records list one 510(k) clearance, 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) clearances
1
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Shu Gie Industrial Co., Ltd. in 1995.

Clearances by year, as a table
510(k) clearance decisions for Shu Gie Industrial Co., Ltd., by decision year
YearClearances
19951
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K945735SUNLGASSES, SPORT SUNGLASSES & FISHING GLASSESHQYSubstantially Equivalent

Registered establishments

FDA registered establishments for Shu Gie Industrial Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
80225471000202649SHU GIE INDUSTRIAL CO., LTD.ROOM NO.16, FL.5, NO.2, CHENG KUNG ROAD, TAINAN CITY 70443 TW2026

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