Levy Articulating Retractor
FDA 510(k) K920471 · Lifeguard Medical Products, Inc.
510(k) numberK920471
Submission
- Device name
- Levy Articulating Retractor
- Applicant
- Lifeguard Medical Products, Inc.
River Forest, IL, US - Received
- January 28, 1992
- Decision date
- June 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAD – Retractor
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K980588 | Clarus Endoscopic Discectomy System Sitetrac Model 6000GAD · Traditional | Clarus Medical Systems, Inc. | 08/18/1998SE |
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Questions and answers
When was Levy Articulating Retractor cleared by the FDA?
Levy Articulating Retractor (K920471) received a 510(k) decision of Substantially Equivalent on June 23, 1992, 147 days after the submission was received.
What is the product code of K920471?
The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.