The following data is part of a premarket notification filed by Elastomade Accessories Sdn Bhd with the FDA for Royal Shield Non-sterile Powder-free Rubber Dams.
| Device ID | K952628 |
| 510k Number | K952628 |
| Device Name: | ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS |
| Classification | Dam, Rubber |
| Applicant | ELASTOMADE ACCESSORIES SDN BHD 89, 2ND FL., JALAN SS 15/4C, SUBANG JAYA Petaling Jaya, MY 47500 |
| Contact | Ong L Mau |
| Correspondent | Ong L Mau ELASTOMADE ACCESSORIES SDN BHD 89, 2ND FL., JALAN SS 15/4C, SUBANG JAYA Petaling Jaya, MY 47500 |
| Product Code | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-08 |
| Decision Date | 1995-10-19 |