GFD — Dermatome Class I
FDA product code GFD covers "Dermatome", a Class I medical device regulated under 21 CFR 878.4820. Submissions are reviewed by the General, Plastic Surgery panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GFD
- Device Class
- Class I
- Regulation Number
- 878.4820
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K965256 | mattioli engineering | DMS-1000C DERMOABRADER | December 9, 1996 |
| K962371 | dsp worldwide | DERMTOME BLADE | August 29, 1996 |
| K945594 | depuy intl | DECA DERMATOME (MICROMOTOR SYSTEM) | June 5, 1995 |
| K951085 | padgett instruments | PADGETT AIR DERMATOME, MODEL A | May 15, 1995 |
| K940208 | aesculap | AESCULAP ACCU-DERMATOME | February 24, 1994 |
| K862669 | u. s. diagnostics | ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST | October 3, 1986 |
| K861285 | precision modified devices | SKIN MESH DEVICE | April 17, 1986 |
| K861138 | mecron medical products | MASH DERMATOME | April 14, 1986 |
| K860925 | mri ventures | DERMASPANDERE | March 28, 1986 |
| K842702 | downs surgical | ROSENBERG SKIN GRAFTING KNIVES | August 2, 1984 |
| K830993 | prothia usa | AMPLIGREFFE | May 3, 1983 |
| K792332 | davol | DAVOL/SIMON DERMATOME | December 6, 1979 |