KELOCOTE
Elastomer, Silicone, For Scar Management
ALLIED BIOMEDICAL CORP.
The following data is part of a premarket notification filed by Allied Biomedical Corp. with the FDA for Kelocote.
Pre-market Notification Details
| Device ID | K954413 |
| 510k Number | K954413 |
| Device Name: | KELOCOTE |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | ALLIED BIOMEDICAL CORP. 3850 DR. #C-2 Paso Robles, CA 93446 |
| Contact | Cathy Ripple |
| Correspondent | Cathy Ripple ALLIED BIOMEDICAL CORP. 3850 DR. #C-2 Paso Robles, CA 93446 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-21 |
| Decision Date | 1995-11-29 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724CSG141 | K954413 | 000 |
| M724CSG051 | K954413 | 000 |
Trademark Results [KELOCOTE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KELOCOTE 75380179 not registered Dead/Abandoned |
Hanson Medical, Inc 1997-10-27 |
 KELOCOTE 75317286 2252503 Dead/Cancelled |
ALLIED BIOMEDICAL CORPORATION 1997-05-16 |
 KELOCOTE 75316711 2238187 Dead/Cancelled |
ALLIED BIOMEDICAL CORPORATION 1997-06-30 |
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