← FDA Medical Device Classifications
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HGO · Class III — High Risk (PMA approval required, life-sustaining) · Obstetrics/Gynecology · 21 CFR 884.2620
Classification
- FDA Product Code
HGO- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 884.2620
- Review panel
- OB
- Medical specialty
- Obstetrics/Gynecology
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown