ISOLYSER
Gauze/sponge, Internal
THANTEX SPECIALTIES, INC.
The following data is part of a premarket notification filed by Thantex Specialties, Inc. with the FDA for Isolyser.
Pre-market Notification Details
| Device ID | K940765 |
| 510k Number | K940765 |
| Device Name: | ISOLYSER |
| Classification | Gauze/sponge, Internal |
| Applicant | THANTEX SPECIALTIES, INC. 4320 INTERNATIONAL BLVD, NW Norcross, GA 30093 |
| Contact | Travis Honeycutt |
| Correspondent | Travis Honeycutt THANTEX SPECIALTIES, INC. 4320 INTERNATIONAL BLVD, NW Norcross, GA 30093 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-18 |
| Decision Date | 1994-12-19 |
Trademark Results [ISOLYSER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ISOLYSER 73835484 1607051 Live/Registered |
ISOLYSER CO., INC. 1989-11-02 |
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