Modification of Surgical Eyeshield Mask
FDA 510(k) K934085 · American Threshold Industries, Inc.
510(k) numberK934085
Submission
- Device name
- Modification of Surgical Eyeshield Mask
- Applicant
- American Threshold Industries, Inc.
Enka, NC, US - Received
- August 20, 1993
- Decision date
- November 12, 1993
- 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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| K952114 | Kool Gard Singles GownFYC · Traditional | 09/25/1995SE |
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| K915530 | Nova Gauze(R) Disposable Nonwoven Sponges, SterileHAX · Traditional | 08/17/1992SE |
| K915740 | Disposable O.R. Towel, SterileKKX · Traditional | 06/22/1992SE |
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Questions and answers
When was Modification of Surgical Eyeshield Mask cleared by the FDA?
Modification of Surgical Eyeshield Mask (K934085) received a 510(k) decision of Substantially Equivalent on November 12, 1993, 84 days after the submission was received.
What is the product code of K934085?
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.