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 |