The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Silastic U-tube Kit.
Device ID | K781526 |
510k Number | K781526 |
Device Name: | SILASTIC U-TUBE KIT |
Classification | Catheter, Nephrostomy, General & Plastic Surgery |
Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GBO |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-09-05 |
Decision Date | 1978-09-20 |