K843693 is an FDA 510(k) clearance for the JACOBS HIGH VACUUM SUCTION UNIT 05-2570. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by J. Sklar Mfg. Co., Inc. (Long Island City, US). The FDA issued a Cleared decision on October 31, 1984, 42 days after receiving the submission on September 19, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K843693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1984 |
| Decision Date | October 31, 1984 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | BTA — Pump, Portable, Aspiration (manual Or Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |