The following data is part of a premarket notification filed by Stainless Mfg., Inc. with the FDA for Banana Knife - K841969-labeling.
Device ID | K841972 |
510k Number | K841972 |
Device Name: | BANANA KNIFE - K841969-LABELING |
Classification | Instrument, Cutting, Orthopedic |
Applicant | STAINLESS MFG., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HTZ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-14 |
Decision Date | 1984-06-19 |