The following data is part of a premarket notification filed by Narco Scientific with the FDA for Disp. Yankaver Surg. Suction Instrument.
Device ID | K830123 |
510k Number | K830123 |
Device Name: | DISP. YANKAVER SURG. SUCTION INSTRUMENT |
Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
Applicant | NARCO SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GCY |
CFR Regulation Number | 878.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-11 |
Decision Date | 1983-06-08 |