The following data is part of a premarket notification filed by H&h Instruments with the FDA for Hhi Pneumatic Rotary Drill.
| Device ID | K922661 |
| 510k Number | K922661 |
| Device Name: | HHI PNEUMATIC ROTARY DRILL |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | H&H INSTRUMENTS 4950 CRESCENT TECHNICAL CT St Augustine, FL 32086 |
| Contact | Mary K Horvath |
| Correspondent | Mary K Horvath H&H INSTRUMENTS 4950 CRESCENT TECHNICAL CT St Augustine, FL 32086 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-03 |
| Decision Date | 1992-09-18 |