The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Silastic Brand Q7-2091 Gastric Sump Tube.
Device ID | K760708 |
510k Number | K760708 |
Device Name: | SILASTIC BRAND Q7-2091 GASTRIC SUMP TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-25 |
Decision Date | 1976-11-23 |