The following data is part of a premarket notification filed by Stainless Mfg., Inc. with the FDA for 2.5mm & 4mm Probe K841969-labeling.
Device ID | K841971 |
510k Number | K841971 |
Device Name: | 2.5MM & 4MM PROBE K841969-LABELING |
Classification | Probe |
Applicant | STAINLESS MFG., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HXB |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-14 |
Decision Date | 1984-06-19 |