NPseal
Negative Pressure Wound Therapy Non-powered Suction Apparatus
Guard Medical Inc
The following data is part of a premarket notification filed by Guard Medical Inc with the FDA for Npseal.
Pre-market Notification Details
| Device ID | K212971 |
| 510k Number | K212971 |
| Device Name: | NPseal |
| Classification | Negative Pressure Wound Therapy Non-powered Suction Apparatus |
| Applicant | Guard Medical Inc 1221 Brickwell Avenue, Suite 900 Miami, FL 33131 |
| Contact | Machiel Van Der Leest |
| Correspondent | Eric Bannon Alvamed Inc 935 Great Plain Ave, Suite 166 Needham, MA 02492 |
| Product Code | OKO |
| CFR Regulation Number | 878.4683 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-17 |
| Decision Date | 2022-02-10 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860004811336 | K212971 | 000 |
| 00860004811329 | K212971 | 000 |
Trademark Results [NPseal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NPSEAL 88000721 not registered Live/Pending |
Guard Medical SAS 2018-06-14 |
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