Auto Lube System
FDA 510(k) K940535 · The Anspach Effort, Inc.
510(k) numberK940535
Submission
- Device name
- Auto Lube System
- Applicant
- The Anspach Effort, Inc.
Palm Beach Gardens, FL, US - Received
- February 7, 1994
- Decision date
- March 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K964252 | OrthochuckGEY · Traditional | Buckman Co., Inc. | 05/27/1997SE |
| K970530 | Anspach Lubricating System IIGEY · Traditional | The Anspach Effort, Inc. | 05/05/1997SE |
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Questions and answers
When was Auto Lube System cleared by the FDA?
Auto Lube System (K940535) received a 510(k) decision of Substantially Equivalent on March 21, 1994, 42 days after the submission was received.
What is the product code of K940535?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.