The following data is part of a premarket notification filed by Allied Biomedical Corp. with the FDA for Kelocate Sheeting.
| Device ID | K982051 |
| 510k Number | K982051 |
| Device Name: | KELOCATE SHEETING |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | ALLIED BIOMEDICAL CORP. 3850 RAMADA DR., SUITE C-2 Paso Robles, CA 93446 |
| Contact | Catherine Riple |
| Correspondent | Catherine Riple ALLIED BIOMEDICAL CORP. 3850 RAMADA DR., SUITE 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 | 1998-06-11 |
| Decision Date | 1998-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724IGSVM1 | K982051 | 000 |
| M724GS18X20T1 | K982051 | 000 |
| M724GS18X025T1 | K982051 | 000 |
| M724GS18X0251 | K982051 | 000 |
| M724GS1215T1 | K982051 | 000 |
| M724GS12151 | K982051 | 000 |
| M724GS10121 | K982051 | 000 |
| M724GS0610T1 | K982051 | 000 |
| M724GS06101 | K982051 | 000 |
| M724GSAC1 | K982051 | 000 |
| M724GSBR1 | K982051 | 000 |
| M724GSLS1 | K982051 | 000 |
| M724IGSLS1 | K982051 | 000 |
| M724IGSBR1 | K982051 | 000 |
| M724IGSAC1 | K982051 | 000 |
| M724IGS18X251 | K982051 | 000 |
| M724IGS12151 | K982051 | 000 |
| M724IGS06101 | K982051 | 000 |
| M724IGS04051 | K982051 | 000 |
| M724GSVM1 | K982051 | 000 |
| M724GS04051 | K982051 | 000 |