← FDA Medical Device Classifications
Tissue Adhesive For The Topical Approximation Of Skin
MPN · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4010
Classification
- FDA Product Code
MPN- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 878.4010
- Review panel
- SU
- Medical specialty
- General, Plastic Surgery
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
Market data
- Cleared 510(k) submissions
- 36
- Registered establishments
- 36
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown