The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Micro-edge Disposable Blades.
Device ID | K832680 |
510k Number | K832680 |
Device Name: | MICRO-EDGE DISPOSABLE BLADES |
Classification | Instrument, Surgical, Disposable |
Applicant | MICROMEDICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-09 |
Decision Date | 1983-10-14 |