Product Code: MCN FDA class 3

Barrier, Absorbable, Adhesion

Unknown

The absorbable adhesion barrier is a bioabsorbable device placed during surgery to prevent the formation of postoperative adhesions between tissues and organs, degrading over time as healing occurs. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The product code is MCN and no regulation number or formal medical specialty has been assigned. The device is not flagged as an implant and does not sustain life.

510(k)s
0
FEI Numbers
20
Registration Numbers
20
Unique Applicants
0
Years Active

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Basic Information

Product Code
MCN
Device Class
FDA class 3
Medical Specialty
Unknown
Review Panel
OB
Submission Type
2

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

FEI Numbers

This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.