← FDA Medical Device Classifications

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HON · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.1605

Classification

FDA Product Code
HON
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 886.1605
Review panel
OP
Medical specialty
Ophthalmic
Submission type
4
GMP exempt
Y
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
0
Registered establishments
4

Source

Authoritative
FDA Device Classification database
Machine
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