The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Davol/simon Dermatome.
Device ID | K792332 |
510k Number | K792332 |
Device Name: | DAVOL/SIMON DERMATOME |
Classification | Dermatome |
Applicant | DAVOL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GFD |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-19 |
Decision Date | 1979-12-06 |