Product code MCA
- Device name
- Tape, Surgical, Internal
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3300
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K900195 | MODIFIED GORE-TEX SURGICAL TAPE | W. L. Gore & Associates, Inc. | 1990-03-13 |
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| 50195594764690 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-08-12 |
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