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Cutaneous Tissue Adhesive With Mesh

FDA product code OMD · 6 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4011
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-04-21 – 2024-07-15

For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations. The device may be used in conjunction with, but not in place of, deep dermal sutures.

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