The following data is part of a premarket notification filed by Pegasus Medical Supply, Inc. with the FDA for Angio-press Dvt Compression Device Model Name: Ipcs.
Device ID | K143202 |
510k Number | K143202 |
Device Name: | ANGIO-PRESS DVT Compression Device Model Name: IPCS |
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 | Michael Lee AcmeBiotechs Co., Ltd. No. 45, Minsheng Rd. Danshui Town New Taipei City, TW 251 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-07 |
Decision Date | 2015-07-07 |
Summary: | summary |