K943836 is an FDA 510(k) clearance for the PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER. This device is classified as a Catheter And Tip, Suction (Class II - Special Controls, product code JOL).
Submitted by Orion Life Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on November 21, 1994, 108 days after receiving the submission on August 5, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K943836 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 1994 |
| Decision Date | November 21, 1994 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | JOL — Catheter And Tip, Suction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |