Rica (Diagnostic Instruments)
FDA 510(k) K810054 · Robert I. Chien & Assoc., Inc.
510(k) numberK810054
Submission
- Device name
- Rica (Diagnostic Instruments)
- Applicant
- Robert I. Chien & Assoc., Inc.
Mchenry, IL, US - Received
- January 12, 1981
- Decision date
- January 28, 1981
- 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 |
| 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 |
| K791336 | Bucks Neurological HammerGWZ · Traditional | Amdia Medical Products | 08/03/1979SE |
More from Amdia Medical Products
| 510(k) | Device | Decision |
|---|---|---|
| K822151 | Surgical Instruments Represent. 4 ClassHNF · Traditional | 08/19/1982SE |
| K811632 | Unsterilized Laparotomy Sponges (China)GDY · Traditional | 09/11/1981SE |
| K811631 | Thermometer (Made in China)FLK · Traditional | 07/20/1981SE |
| K801819 | Surgical InstrumentsHXD · Traditional | 08/20/1980SE |
| K801028 | Rica or Smic Surgical InstrumentsHXD · Traditional | 05/20/1980SE |
Questions and answers
When was Rica (Diagnostic Instruments) cleared by the FDA?
Rica (Diagnostic Instruments) (K810054) received a 510(k) decision of Substantially Equivalent on January 28, 1981, 16 days after the submission was received.
What is the product code of K810054?
The FDA product code is GWZ – Percussor, a Class I (low risk) device regulated under 21 CFR 882.1700.