DAVOL/SIMON DERMATOME
FDA 510(k) clearance K792332 · decided 1979-12-06
Clearance details
- K-number
- K792332
- Device name
- DAVOL/SIMON DERMATOME
- Applicant
- Davol, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-11-19
- Decision date
- 1979-12-06
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- GFD
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DMS-1000C DERMOABRADER (K965256) | Mattioli Engineering, Srl | 1996-12-09 |
| DERMTOME BLADE (K962371) | Dsp Worldwide | 1996-08-29 |
| DECA DERMATOME (MICROMOTOR SYSTEM) (K945594) | Depuy Intl., Ltd. | 1995-06-05 |
| PADGETT AIR DERMATOME, MODEL A (K951085) | Padgett Instruments, Inc. | 1995-05-15 |
| AESCULAP ACCU-DERMATOME (K940208) | Aesculap, Inc. | 1994-02-24 |
| ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (K862669) | U. S. Diagnostics, Inc. | 1986-10-03 |
| SKIN MESH DEVICE (K861285) | Precision Modified Devices | 1986-04-17 |
| MASH DERMATOME (K861138) | Mecron Medical Products, Inc. | 1986-04-14 |
| DERMASPANDERE (K860925) | Mri Ventures, Inc. | 1986-03-28 |
| ROSENBERG SKIN GRAFTING KNIVES (K842702) | Downs Surgical , Ltd. | 1984-08-02 |
| AMPLIGREFFE (K830993) | Prothia USA, Inc. | 1983-05-03 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Arista AH (P050038/S042) | Davol, Inc. | 2024-11-04 |
| Arista AH (P050038/S040) | Davol, Inc. | 2023-08-09 |
| FlexiTip XL-R Applicator (P050038/S041) | Davol, Inc. | 2023-05-24 |
| Arista AH Absorbable Hemostatic Particles device (P050038/S038) | Davol, Inc. | 2021-10-22 |
| Arista AH Absorbable Hemostatic Particles Device (P050038/S039) | Davol, Inc. | 2021-08-20 |
| Arista AH Absorbable Hemostatic Particles (P050038/S037) | Davol, Inc. | 2021-07-06 |
| Arista AH Absorbable Hemostatic (P050038/S036) | Davol, Inc. | 2020-09-25 |
| Arista AH Absorbable Hemostatic Particles (P050038/S035) | Davol, Inc. | 2020-04-29 |