The following data is part of a premarket notification filed by Nhr, Inc. with the FDA for Skin Biopsy Device.
| Device ID | K933324 |
| 510k Number | K933324 |
| Device Name: | SKIN BIOPSY DEVICE |
| Classification | Device, Percutaneous, Biopsy |
| Applicant | NHR, INC. 1314 MACOMB Monroe, MI |
| Contact | Hossein Nabai |
| Correspondent | Hossein Nabai NHR, INC. 1314 MACOMB Monroe, MI |
| Product Code | MJG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-12 |
| Decision Date | 1994-03-31 |