Bucks Neurological Hammer
FDA 510(k) K791336 · Amdia Medical Products
510(k) numberK791336
Submission
- Device name
- Bucks Neurological Hammer
- Applicant
- Amdia Medical Products
Mchenry, IL, US - Received
- July 20, 1979
- Decision date
- August 3, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GWZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891571 | Percussion HammerGWZ · Traditional | Sandal Surgico | 03/31/1989SE |
| K852716 | Taylor Percussion Hammer SS 410 or 420GWZ · Traditional | The Huxley Instrument Corp. | 07/26/1985SE |
| K851748 | 1/310, 1-320 Percussion Hammers,Taylor, DejerineGWZ · Traditional | Artiberia | 06/13/1985SE |
| K840314 | Cat 10-NEUROLOGY DeviceGWZ · Traditional | Imm Enterprises , Ltd. | 02/23/1984SE |
| K834178 | H.R. Jakobi Surg. Instr. #10 34/36GWZ · Traditional | Imm Enterprises , Ltd. | 02/23/1984SE |
| K834170 | Op-Con Surg. Instrument #10GWZ · Traditional | Imm Enterprises , Ltd. | 02/23/1984SE |
| K810054 | Rica (Diagnostic Instruments)GWZ · Traditional | Robert I. Chien & Assoc., Inc. | 01/28/1981SE |
| K803148 | Conphar Percussion Hammer(Taylor)GWZ · Traditional | Conphar, Inc. | 01/08/1981SE |
| K803174 | Conphar Percussion Hammer(Buck Type)GWZ · Traditional | Conphar, Inc. | 12/30/1980SE |
| K791337 | Taylor Neurological HammerGWZ · Traditional | Amdia Medical Products | 08/03/1979SE |
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Questions and answers
When was Bucks Neurological Hammer cleared by the FDA?
Bucks Neurological Hammer (K791336) received a 510(k) decision of Substantially Equivalent on August 3, 1979, 14 days after the submission was received.
What is the product code of K791336?
The FDA product code is GWZ – Percussor, a Class I (low risk) device regulated under 21 CFR 882.1700.