The following data is part of a premarket notification filed by Med-tool, Inc. with the FDA for Combination Wrenches.
Device ID | K874358 |
510k Number | K874358 |
Device Name: | COMBINATION WRENCHES |
Classification | Wrench |
Applicant | MED-TOOL, INC. 12434 MATTHEWS LN. St. Louis, MO 63127 |
Contact | John Mayerik |
Correspondent | John Mayerik MED-TOOL, INC. 12434 MATTHEWS LN. St. Louis, MO 63127 |
Product Code | HXC |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-23 |
Decision Date | 1987-11-23 |