SEPRAGEL SINUS
Splint, Intranasal Septal
GENZYME CORP.
The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Sepragel Sinus.
Pre-market Notification Details
| Device ID | K012532 |
| 510k Number | K012532 |
| Device Name: | SEPRAGEL SINUS |
| Classification | Splint, Intranasal Septal |
| Applicant | GENZYME CORP. 1125 PLEASANT VIEW TERRANCE Ridgefield, NJ 07657 |
| Contact | Nancy A Immel |
| Correspondent | Nancy A Immel GENZYME CORP. 1125 PLEASANT VIEW TERRANCE Ridgefield, NJ 07657 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2001-10-30 |
| Summary: | summary |
Trademark Results [SEPRAGEL SINUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SEPRAGEL SINUS 86615390 not registered Dead/Abandoned |
Genzyme Corporation 2015-04-30 |
 SEPRAGEL SINUS 86615299 not registered Dead/Abandoned |
Genzyme Corporation 2015-04-30 |
 SEPRAGEL SINUS 78789020 3145614 Dead/Cancelled |
GENZYME CORPORATION 2006-01-11 |
 SEPRAGEL SINUS 78736180 3142096 Dead/Cancelled |
GENZYME CORPORATION 2005-10-19 |
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