The following data is part of a premarket notification filed by Geometric Data, Div. Smithkline Corp. with the FDA for Hemaspinner.
Device ID | K811534 |
510k Number | K811534 |
Device Name: | HEMASPINNER |
Classification | Spinner, Slide, Automated |
Applicant | GEOMETRIC DATA, DIV. SMITHKLINE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GKJ |
CFR Regulation Number | 864.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-01 |
Decision Date | 1981-08-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HEMASPINNER 73388422 1260421 Dead/Cancelled |
SmithKline Beckman Corporation 1982-09-24 |