Evans Arm and Hand Rest
FDA 510(k) K760697 · Alcon Laboratories
510(k) numberK760697
Submission
- Device name
- Evans Arm and Hand Rest
- Applicant
- Alcon Laboratories
Mchenry, IL, US - Received
- September 22, 1976
- Decision date
- November 2, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HRK – Table, Instrument, Manual, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4855
- Specialty
- Ophthalmic
Other 510(k)s with product code HRK
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|---|---|---|---|
| K842410 | Amer. Edwards Lab FlexiscopeHRK · Traditional | American Edwards Laboratories | 11/05/1984SE |
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Questions and answers
When was Evans Arm and Hand Rest cleared by the FDA?
Evans Arm and Hand Rest (K760697) received a 510(k) decision of Substantially Equivalent on November 2, 1976, 41 days after the submission was received.
What is the product code of K760697?
The FDA product code is HRK – Table, Instrument, Manual, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4855.