K823648 is an FDA 510(k) clearance for the SURGICAL TUBING. This device is classified as a Components, Exercise (Class I - General Controls, product code IOD).
Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1983, 46 days after receiving the submission on December 6, 1982.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5350.
| 510(k) Number | K823648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 1982 |
| Decision Date | January 21, 1983 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IOD — Components, Exercise |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5350 |