K770108 is an FDA 510(k) clearance for the TUBE HOLDING DEVICE. This device is classified as a Tubing, Fluid Delivery (Class II - Special Controls, product code FPK).
Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1977, 52 days after receiving the submission on January 17, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K770108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 1977 |
| Decision Date | March 10, 1977 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FPK — Tubing, Fluid Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |