510(k) K940208
- Device
- Aesculap Accu-dermatome
- Applicant
- AESCULAP, INC.
- 510(k) number
- K940208
- Product code
- GFD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-02-24
- Date received
- 1994-01-14
- Regulation
- 878.4820
- Classification name
- Dermatome
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY ELLEN HOLDEN
- Address
- 1000 Gateway Blvd. South San Francisco CA US 94080 94080
FDA Registration Numbers#
- 1058584
- 9680411
- 3004112621
- 3023657851
- 3013557562
- 2084346
- 1018233
- 9611274
- 3008808560
- 3014328942
- 3018784829
- 3007137643
- 3009039068
- 1421879
- 9680741
- 3002807314
- 1219518
- 9680890
- 3016069968
- 1836161
- 3023244395
- 3005205318
- 8040278
- 3035678069
- 3010687973
- 1319639
- 3002808022
- 1722447
- 3022320321
- 3010402752
- 3011547157
- 3008770252
- 3011554142
- 2916714
- 2029275
- 3007773213
- 1526350
- 3026264
- 3002808145
- 3013784566
- 1424263
- 9611283
- 3016678045
- 3018068202
- 3009736547
- 3003587896
- 3015136927
- 3007648354
- 1054811
- 8043750
- 3004608878
- 3008950755
- 1526534
- 3012226300
- 9611484
- 8030607
- 3012366928
- 9611503
- 3009518429
- 1822565
- 3005695724
- 3003418325
- 3003244954
- 3011981870
- 3030733800
- 9610612
- 3007751444
- 9680718
- 3009513193
- 3013901429
- 1222274
Source Documents#
Other 510(k) Records For Product Code GFD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K965256 | DMS-1000C DERMOABRADER | Mattioli Engineering, Srl | 1996-12-09 |
| K962371 | DERMTOME BLADE | Dsp Worldwide | 1996-08-29 |
| K945594 | DECA DERMATOME (MICROMOTOR SYSTEM) | Depuy Intl., Ltd. | 1995-06-05 |
| K951085 | PADGETT AIR DERMATOME, MODEL A | Padgett Instruments, Inc. | 1995-05-15 |
| K862669 | ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST | U. S. Diagnostics, Inc. | 1986-10-03 |
| K861285 | SKIN MESH DEVICE | Precision Modified Devices | 1986-04-17 |
| K861138 | MASH DERMATOME | Mecron Medical Products, Inc. | 1986-04-14 |
| K860925 | DERMASPANDERE | Mri Ventures, Inc. | 1986-03-28 |
| K842702 | ROSENBERG SKIN GRAFTING KNIVES | Downs Surgical , Ltd. | 1984-08-02 |
| K830993 | AMPLIGREFFE | Prothia USA, Inc. | 1983-05-03 |
| K792332 | DAVOL/SIMON DERMATOME | Davol, Inc. | 1979-12-06 |