The following data is part of a premarket notification filed by I-ming Sanitary Materials Co., Ltd. with the FDA for 1-m Graduated Compression Anti-embolism Stocking, Model Ss-811, Ss-508, Ss-613.
| Device ID | K092892 |
| 510k Number | K092892 |
| Device Name: | 1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613 |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | I-MING SANITARY MATERIALS CO., LTD. 101-10 DU TU LN., ER HSI RD., PEISHIH LI Hsihu, Chang Hua, TW |
| Contact | Sara Hou |
| Correspondent | Sara Hou I-MING SANITARY MATERIALS CO., LTD. 101-10 DU TU LN., ER HSI RD., PEISHIH LI Hsihu, Chang Hua, TW |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-21 |
| Decision Date | 2010-08-03 |