GELZONE
Elastomer, Silicone, For Scar Management
IMPLANTECH ASSOCIATES, INC.
The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Gelzone.
Pre-market Notification Details
| Device ID | K013732 |
| 510k Number | K013732 |
| Device Name: | GELZONE |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | IMPLANTECH ASSOCIATES, INC. 2064 EASTMAN AVE., UNIT 101 Ventura, CA 93003 |
| Contact | Stephen Meade |
| Correspondent | Stephen Meade IMPLANTECH ASSOCIATES, INC. 2064 EASTMAN AVE., UNIT 101 Ventura, CA 93003 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-09 |
| Decision Date | 2002-02-07 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724WRAP648NL1 | K013732 | 000 |
| M724WRAP1048NL1 | K013732 | 000 |
| M724WRAP1121 | K013732 | 000 |
| M724WRAP2121 | K013732 | 000 |
| M724WRAP2161 | K013732 | 000 |
| M724WRAP4121 | K013732 | 000 |
| M724WRAP4241 | K013732 | 000 |
| M724WRAP4401 | K013732 | 000 |
| M724WRAP6481 | K013732 | 000 |
| M724WRAP10481 | K013732 | 000 |
Trademark Results [GELZONE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GELZONE 98201734 not registered Live/Pending |
The Helping Hand Company (Ledbury) Limited 2023-09-28 |
 GELZONE 76297842 2782583 Live/Registered |
GELZONE, INC. 2001-08-09 |
 GELZONE 76297841 2787073 Live/Registered |
GELZONE, INC. 2001-08-09 |
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