The following data is part of a premarket notification filed by Top Calibre Sdn Bhd with the FDA for Multiple Name.
| Device ID | K123819 |
| 510k Number | K123819 |
| Device Name: | MULTIPLE NAME |
| Classification | Latex Patient Examination Glove |
| Applicant | TOP CALIBRE SDN BHD 1-1,2 JALAN SETIA PRIMA U13/S SETIA ALAM, SEKSYEN U13 Shah Alam, Selangor, MY 40170 |
| Contact | Rosnita Maodin |
| Correspondent | Rosnita Maodin TOP CALIBRE SDN BHD 1-1,2 JALAN SETIA PRIMA U13/S SETIA ALAM, SEKSYEN U13 Shah Alam, Selangor, MY 40170 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-12 |
| Decision Date | 2013-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30851253007770 | K123819 | 000 |
| 30851253007763 | K123819 | 000 |
| 30851253007756 | K123819 | 000 |
| 30851253007749 | K123819 | 000 |
| 30850015055097 | K123819 | 000 |
| 30850015055080 | K123819 | 000 |
| 30850015055073 | K123819 | 000 |
| 30850015055066 | K123819 | 000 |