Elastomade Accessories Sdn Bhd
Port Klang Selangor, MY
ELASTOMADE ACCESSORIES SDN BHD appears in FDA device records in Port Klang Selangor, MY. 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 Elastomade Accessories Sdn Bhd between 1991 and 1995. The busiest year on record is 1991, with 1. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K952628 | ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS | EIE | Substantially Equivalent | |
| K942992 | ROYAL SHIELD RUBBER DAMS | EIE | Substantially Equivalent | |
| K905470 | STANDARD RUBBER DAM WITH OR WITHOUT FRAMES | EIE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005822857 | 3005822857 | ELASTOMADE ACCESSORIES SDN BHD | Lot 7, Lengkungan Hishamuddin, Kawasan Perusahaan Selat Klang Utara, Port Klang Selangor 42000 MY | 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