The following data is part of a premarket notification filed by Ascep, Inc. with the FDA for Instruments Nonsterile & Sterile.
Device ID | K802726 |
510k Number | K802726 |
Device Name: | INSTRUMENTS NONSTERILE & STERILE |
Classification | Instrument, Surgical, Non-powered |
Applicant | ASCEP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HAO |
CFR Regulation Number | 882.4535 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-27 |
Decision Date | 1980-11-19 |