FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTABOND Topical Skin Adhesive
K Number: K161050
·
Decision Oct 4, 2016
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
35
Applicant Total
1
Review Days
173
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Basic Information
- Device Name
- ACTABOND Topical Skin Adhesive
- K Number
- K161050
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4010
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bergen Medical Products, Inc.
- Date Received
- April 14, 2016
- Decision Date
- October 4, 2016
- Product Code
- MPN
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | FDA class 2 | General, Plastic Surgery |
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