The following data is part of a premarket notification filed by Padgett Instruments, Inc. with the FDA for Padgett Air Dermatome, Model A.
| Device ID | K951085 |
| 510k Number | K951085 |
| Device Name: | PADGETT AIR DERMATOME, MODEL A |
| Classification | Dermatome |
| Applicant | PADGETT INSTRUMENTS, INC. 1730 WALNUT ST. Kansas City, MO 64108 |
| Contact | Joel N Waldman |
| Correspondent | Joel N Waldman PADGETT INSTRUMENTS, INC. 1730 WALNUT ST. Kansas City, MO 64108 |
| Product Code | GFD |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-09 |
| Decision Date | 1995-05-15 |