Sterile View(Tm) Hi Effic Helmet/Back PK Sup/Exhau
FDA 510(k) K914694 · Depuy, Inc.
510(k) numberK914694
Submission
- Device name
- Sterile View(Tm) Hi Effic Helmet/Back PK Sup/Exhau
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- October 18, 1991
- Decision date
- January 16, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Sterile View(Tm) Hi Effic Helmet/Back PK Sup/Exhau cleared by the FDA?
Sterile View(Tm) Hi Effic Helmet/Back PK Sup/Exhau (K914694) received a 510(k) decision of Substantially Equivalent on January 16, 1992, 90 days after the submission was received.
What is the product code of K914694?
The FDA product code is JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 878.4780.