Submission Details
| 510(k) Number | K980336 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 28, 1998 |
| Decision Date | April 06, 1998 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
IV STANDS
Apr 1998
Decision
68d
Days
Class 1
Risk
About This 510(k) Submission
K980336 is an FDA 510(k) clearance for the IV STANDS, a Stand, Infusion (Class I — General Controls, product code FOX), submitted by Clinton Industries, Inc. (Doylestown, US). The FDA issued a Cleared decision on April 6, 1998, 68 days after receiving the submission on January 28, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6990.
Device Classification
| Product Code | FOX — Stand, Infusion |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.6990 |
Manufacturer
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