Device Classification Name |
negative pressure wound therapy non-powered suction apparatus
|
510(k) Number |
K200305 |
Device Name |
NPseal |
Applicant |
Guard Medical Inc. |
10 East 40th Street, Suite 3310 |
New York,
NY
10016
|
|
Applicant Contact |
Machiel Van der Leest |
Correspondent |
AlvaMed, Inc. |
935 Great Plain Avenue, #166 |
Needham,
MA
02492
|
|
Correspondent Contact |
Eric Bannon |
Regulation Number | 878.4683
|
Classification Product Code |
|
Date Received | 02/06/2020 |
Decision Date | 05/26/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|