← FDA Medical Device Classifications
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HKN · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.1770
Classification
- FDA Product Code
HKN- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 886.1770
- 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
- 3
- Registered establishments
- 62
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown