The following data is part of a premarket notification filed by Medicamat S.a. with the FDA for Calvitron Hair Transplant System.
| Device ID | K952737 |
| 510k Number | K952737 |
| Device Name: | CALVITRON HAIR TRANSPLANT SYSTEM |
| Classification | Stylet, Surgical, General & Plastic Surgery |
| Applicant | MEDICAMAT S.A. 1776 K STREET, N.W. Washington, DC 20006 |
| Contact | Andrew S Krulwich |
| Correspondent | Andrew S Krulwich MEDICAMAT S.A. 1776 K STREET, N.W. Washington, DC 20006 |
| Product Code | GAH |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-15 |
| Decision Date | 1995-10-03 |