The following data is part of a premarket notification filed by Medipurpose Pte. Ltd. with the FDA for Surgilance Safety Lancets, Models Sln100, Sln200, Sln240, Sln300, Slb200, Slb250.
| Device ID | K101145 |
| 510k Number | K101145 |
| Device Name: | SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 |
| Classification | Lancet, Blood |
| Applicant | MEDIPURPOSE PTE. LTD. 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
| Contact | Julie Stephens |
| Correspondent | Julie Stephens MEDIPURPOSE PTE. LTD. 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-23 |
| Decision Date | 2010-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817643022128 | K101145 | 000 |
| 58886354701049 | K101145 | 000 |
| 58886354701056 | K101145 | 000 |
| 58886354701063 | K101145 | 000 |
| 58886354701070 | K101145 | 000 |
| 58886354701087 | K101145 | 000 |
| 58886354702145 | K101145 | 000 |
| 58886354702183 | K101145 | 000 |
| 58886354702190 | K101145 | 000 |
| 58886354702206 | K101145 | 000 |
| 58886354702213 | K101145 | 000 |
| 58886354702220 | K101145 | 000 |
| 58886354702237 | K101145 | 000 |
| 58886354702244 | K101145 | 000 |
| 00817643022098 | K101145 | 000 |
| 00817643022104 | K101145 | 000 |
| 00817643022111 | K101145 | 000 |
| 58886354701032 | K101145 | 000 |