Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack
FDA 510(k) K050648 · Advanced Medical Optics, Inc.
510(k) numberK050648
Submission
- Device name
- Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack
- Applicant
- Advanced Medical Optics, Inc.
Santa Ana, CA, US - Received
- March 14, 2005
- Decision date
- April 5, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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Questions and answers
When was Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack cleared by the FDA?
Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack (K050648) received a 510(k) decision of Substantially Equivalent on April 5, 2005, 22 days after the submission was received.
What is the product code of K050648?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.