The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Drill, Cordless Surgical.
Device ID | K790063 |
510k Number | K790063 |
Device Name: | DRILL, CORDLESS SURGICAL |
Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KIJ |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-15 |
Decision Date | 1979-02-05 |