Orthochuck
FDA 510(k) K964252 · Buckman Co., Inc.
510(k) numberK964252
Submission
- Device name
- Orthochuck
- Applicant
- Buckman Co., Inc.
Concord, CA, US - Received
- October 24, 1996
- Decision date
- May 27, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K971782 | Bone and Marrow Collection System KitGEY · Traditional | Biomedical Ent., Inc. | 07/29/1997SE |
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| K970530 | Anspach Lubricating System IIGEY · Traditional | The Anspach Effort, Inc. | 05/05/1997SE |
| K964073 | Bme Bone Drill BitsGEY · Traditional | Biomedical Ent., Inc. | 11/14/1996SE |
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Questions and answers
When was Orthochuck cleared by the FDA?
Orthochuck (K964252) received a 510(k) decision of Substantially Equivalent on May 27, 1997, 215 days after the submission was received.
What is the product code of K964252?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.