The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Instrument Tip Protection Covers.
Device ID | K834127 |
510k Number | K834127 |
Device Name: | INSTRUMENT TIP PROTECTION COVERS |
Classification | Guard, Instrument |
Applicant | DEVON INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LXZ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-29 |
Decision Date | 1984-02-17 |