510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Innolatex (Thailand) Limited

Hat Yai Songkhla, TH

INNOLATEX (THAILAND) LIMITED appears in FDA device records in Hat Yai Songkhla, TH. 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 Innolatex (Thailand) Limited in 2010.

Clearances by year, as a table
510(k) clearance decisions for Innolatex (Thailand) Limited, by decision year
YearClearances
20101
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K092586MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LUHISSubstantially Equivalent

Registered establishments

FDA registered establishments for Innolatex (Thailand) Limited, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30078294813007829481INNOLATEX (THAILAND) LIMITEDLot E1-6 Export Processing Zone, Southern Industrial Estate, Hat Yai Songkhla 90110 TH2026

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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain