The following data is part of a premarket notification filed by Microbio-medics, Inc. with the FDA for Disposable Arachnoid Knife.
Device ID | K882422 |
510k Number | K882422 |
Device Name: | DISPOSABLE ARACHNOID KNIFE |
Classification | Instrument, Surgical, Non-powered |
Applicant | MICROBIO-MEDICS, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
Contact | Keith Mcgee |
Correspondent | Keith Mcgee MICROBIO-MEDICS, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
Product Code | HAO |
CFR Regulation Number | 882.4535 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-13 |
Decision Date | 1988-09-06 |