Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K173012 |
Device Name |
ANGIO-PRESS LITE DVT Compression Device |
Applicant |
Pegasus Medical Supply, Inc. |
No. 27-1, Ln. 473, Sec. 2, Hezun N. Rd., Zhongli City |
Taoyuan County,
TW
32060
|
|
Applicant Contact |
Pao-Ming Shih |
Correspondent |
Pegasus Medical Supply, Inc. |
No. 27-1, Ln. 473, Sec. 2, Hezun N. Rd., Zhongli City |
Taoyuan County,
TW
32060
|
|
Correspondent Contact |
Pao-Ming Shih |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 09/27/2017 |
Decision Date | 05/10/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|