The following data is part of a premarket notification filed by Med-tool, Inc. with the FDA for Pin Punch.
Device ID | K874356 |
510k Number | K874356 |
Device Name: | PIN PUNCH |
Classification | Punch, Surgical |
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 | LRY |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-23 |
Decision Date | 1987-11-23 |