The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for The Kirschner Universal Power Tool System.
| Device ID | K901455 |
| 510k Number | K901455 |
| Device Name: | THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Contact | Sam Son |
| Correspondent | Sam Son KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-02 |
| Decision Date | 1990-05-14 |