Storz Microseal Phacoemulsification Needles (Importation)
FDA 510(k) K951824 · Nidek, Inc.
510(k) numberK951824
Submission
- Device name
- Storz Microseal Phacoemulsification Needles (Importation)
- Applicant
- Nidek, Inc.
Fremont, CA, US - Received
- April 20, 1995
- Decision date
- July 19, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Storz Microseal Phacoemulsification Needles (Importation) cleared by the FDA?
Storz Microseal Phacoemulsification Needles (Importation) (K951824) received a 510(k) decision of Substantially Equivalent on July 19, 1995, 90 days after the submission was received.
What is the product code of K951824?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.