HEMOPORE
Splint, Intranasal Septal
Polyganics BV
The following data is part of a premarket notification filed by Polyganics Bv with the FDA for Hemopore.
Pre-market Notification Details
| Device ID | K141816 |
| 510k Number | K141816 |
| Device Name: | HEMOPORE |
| Classification | Splint, Intranasal Septal |
| Applicant | Polyganics BV ROZENBURGLAAN 15A Groningen, NL 9727dl |
| Contact | Betty Ijmker |
| Correspondent | Betty Ijmker Polyganics BV ROZENBURGLAAN 15A Groningen, NL 9727dl |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-07 |
| Decision Date | 2014-10-23 |
| Summary: | summary |
Trademark Results [HEMOPORE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMOPORE 79121796 4456976 Live/Registered |
Stryker European Holdings I, LLC 2012-10-16 |
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