The following data is part of a premarket notification filed by Medical Z, S.a. with the FDA for Medical Z, S.a. Medigel Z Scar Management Gel.
| Device ID | K971916 |
| 510k Number | K971916 |
| Device Name: | MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | MEDICAL Z, S.A. 1900 K STREET, N.W. Washington, DC 20006 -1108 |
| Contact | Emalee G Murphy |
| Correspondent | Emalee G Murphy MEDICAL Z, S.A. 1900 K STREET, N.W. Washington, DC 20006 -1108 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-23 |
| Decision Date | 1997-07-29 |
| Summary: | summary |