The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Silcath.
Device ID | K834091 |
510k Number | K834091 |
Device Name: | SILCATH |
Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
Applicant | HDC CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LJS |
CFR Regulation Number | 880.5970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-28 |
Decision Date | 1984-03-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SILCATH 73479608 not registered Dead/Abandoned |
HDC CORPORATION 1984-05-09 |