The following data is part of a premarket notification filed by Statlabs, Inc. with the FDA for Twin-fusor/uni-fusor Blood & Fluid Infusion Cuff.
| Device ID | K893519 |
| 510k Number | K893519 |
| Device Name: | TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF |
| Classification | Automated Colony Counter |
| Applicant | STATLABS, INC. 169 LONDON LN. Franklin, TN 37064 |
| Contact | Andy Woods |
| Correspondent | Andy Woods STATLABS, INC. 169 LONDON LN. Franklin, TN 37064 |
| Product Code | KZB |
| CFR Regulation Number | 866.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-08 |
| Decision Date | 1989-08-15 |