The following data is part of a premarket notification filed by Stainless Mfg., Inc. with the FDA for Meniscotome.
Device ID | K800732 |
510k Number | K800732 |
Device Name: | MENISCOTOME |
Classification | Instrument, Bending Or Contouring |
Applicant | STAINLESS MFG., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HXP |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-01 |
Decision Date | 1980-04-08 |