The following data is part of a premarket notification filed by Pegasus Medical Supply, Inc. with the FDA for Angio-press Lite Dvt Compression Device.
| Device ID | K173012 |
| 510k Number | K173012 |
| Device Name: | ANGIO-PRESS LITE DVT Compression Device |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Pegasus Medical Supply, Inc. No. 27-1, Ln. 473, Sec. 2, Hezun N. Rd., Zhongli City Taoyuan County, TW 32060 |
| Contact | Pao-ming Shih |
| Correspondent | Pao-ming Shih Pegasus Medical Supply, Inc. No. 27-1, Ln. 473, Sec. 2, Hezun N. Rd., Zhongli City Taoyuan County, TW 32060 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2018-05-10 |
| Summary: | summary |