Makar Full and Half Face Shield
FDA 510(k) K942828 · Instrument Makar, Inc.
510(k) numberK942828
Submission
- Device name
- Makar Full and Half Face Shield
- Applicant
- Instrument Makar, Inc.
Okemos, MI, US - Received
- June 14, 1994
- Decision date
- February 23, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LYU – Accessory, Surgical Apparel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Makar Full and Half Face Shield cleared by the FDA?
Makar Full and Half Face Shield (K942828) received a 510(k) decision of Substantially Equivalent on February 23, 1995, 254 days after the submission was received.
What is the product code of K942828?
The FDA product code is LYU – Accessory, Surgical Apparel, a Class I (low risk) device regulated under 21 CFR 878.4040.