Amo Prestige Day Pack (Allergan, Inc.)
FDA 510(k) K962402 · Allergan, Inc.
510(k) numberK962402
Submission
- Device name
- Amo Prestige Day Pack (Allergan, Inc.)
- Applicant
- Allergan, Inc.
Irvine, CA, US - Received
- June 21, 1996
- Decision date
- September 19, 1996
- 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 Amo Prestige Day Pack (Allergan, Inc.) cleared by the FDA?
Amo Prestige Day Pack (Allergan, Inc.) (K962402) received a 510(k) decision of Substantially Equivalent on September 19, 1996, 90 days after the submission was received.
What is the product code of K962402?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.