The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Silastic Intravenous Catheter Unit.
Device ID | K790914 |
510k Number | K790914 |
Device Name: | SILASTIC INTRAVENOUS CATHETER UNIT |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-14 |
Decision Date | 1979-07-03 |