The following data is part of a premarket notification filed by Hyland Therapeutic Div., Travenol Laboratories with the FDA for Low Ionic Strength Solution (liss).
| Device ID | K791113 |
| 510k Number | K791113 |
| Device Name: | LOW IONIC STRENGTH SOLUTION (LISS) |
| Classification | Media, Potentiating For In Vitro Diagnostic Use |
| Applicant | HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSG |
| CFR Regulation Number | 864.9600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-15 |
| Decision Date | 1979-06-28 |