Unidirectional Occluder
FDA 510(k) K913230 · Welch Allyn, Inc.
510(k) numberK913230
Submission
- Device name
- Unidirectional Occluder
- Applicant
- Welch Allyn, Inc.
Skaneateles Falls, NY, US - Received
- July 22, 1991
- Decision date
- October 2, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HOY – Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4750
- Specialty
- Ophthalmic
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Questions and answers
When was Unidirectional Occluder cleared by the FDA?
Unidirectional Occluder (K913230) received a 510(k) decision of Substantially Equivalent on October 2, 1991, 72 days after the submission was received.
What is the product code of K913230?
The FDA product code is HOY – Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear), a Class I (low risk) device regulated under 21 CFR 886.4750.