ANGIO-PRESS DVT Compression Device Model Name: IPCS

Sleeve, Limb, Compressible

Pegasus Medical Supply, Inc.

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.

Pre-market Notification Details

Device IDK143202
510k NumberK143202
Device Name:ANGIO-PRESS DVT Compression Device Model Name: IPCS
ClassificationSleeve, Limb, Compressible
Applicant Pegasus Medical Supply, Inc. No. 27-1, Ln. 473, Sec. 2, Hezun N. Rd., Zhongli City Taoyuan County,  TW 32060
ContactPao-ming Shih
CorrespondentMichael Lee
AcmeBiotechs Co., Ltd. No. 45, Minsheng Rd. Danshui Town New Taipei City,  TW 251
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-07
Decision Date2015-07-07
Summary:summary

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