The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Magnetic Drape - Instrument Holder.
Device ID | K780865 |
510k Number | K780865 |
Device Name: | MAGNETIC DRAPE - INSTRUMENT HOLDER |
Classification | Drape, Surgical |
Applicant | DEVON INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-05-30 |
Decision Date | 1978-08-21 |