The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Directdraw Superserum-g Directdraw Superserum-mini-g.
Device ID | K941159 |
510k Number | K941159 |
Device Name: | DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
Contact | Robert N Borghese |
Correspondent | Robert N Borghese INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-11 |
Decision Date | 1994-05-19 |