The following data is part of a premarket notification filed by Mecron Medical Products, Inc. with the FDA for Mash Dermatome.
| Device ID | K861138 |
| 510k Number | K861138 |
| Device Name: | MASH DERMATOME |
| Classification | Dermatome |
| Applicant | MECRON MEDICAL PRODUCTS, INC. 938 PORT WASHINGTON BLVD. P.O. BOX 1139 Port Washington, NY 11050 |
| Contact | Emmanuel Anapliotis |
| Correspondent | Emmanuel Anapliotis MECRON MEDICAL PRODUCTS, INC. 938 PORT WASHINGTON BLVD. P.O. BOX 1139 Port Washington, NY 11050 |
| Product Code | GFD |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-26 |
| Decision Date | 1986-04-14 |