The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Flat Suction Drain.
Device ID | K830610 |
510k Number | K830610 |
Device Name: | FLAT SUCTION DRAIN |
Classification | Lamp, Surgical, Incandescent |
Applicant | SIL-MED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GBC |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-25 |
Decision Date | 1983-03-29 |