Quitetip
FDA 510(k) K981109 · Paradigm Medical Industries, Inc.
510(k) numberK981109
Submission
- Device name
- Quitetip
- Applicant
- Paradigm Medical Industries, Inc.
Salt Lake City, UT, US - Received
- March 27, 1998
- Decision date
- June 9, 1998
- 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 Quitetip cleared by the FDA?
Quitetip (K981109) received a 510(k) decision of Substantially Equivalent on June 9, 1998, 74 days after the submission was received.
What is the product code of K981109?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.