The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Armor-kot Surgical Instruments.
Device ID | K771680 |
510k Number | K771680 |
Device Name: | ARMOR-KOT SURGICAL INSTRUMENTS |
Classification | Tray, Surgical, Instrument |
Applicant | STORZ INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-09-06 |
Decision Date | 1977-11-28 |