The following data is part of a premarket notification filed by Med-tool, Inc. with the FDA for Standard Screw Driver.
Device ID | K872387 |
510k Number | K872387 |
Device Name: | STANDARD SCREW DRIVER |
Classification | Screwdriver, Surgical |
Applicant | MED-TOOL, INC. 12434 MATTHEWS LN. St. Louis, MO 63127 |
Contact | Mayerik, Jr. |
Correspondent | Mayerik, Jr. MED-TOOL, INC. 12434 MATTHEWS LN. St. Louis, MO 63127 |
Product Code | LRZ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-19 |
Decision Date | 1987-07-16 |