Submission Details
| 510(k) Number | K880681 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 19, 1988 |
| Decision Date | April 29, 1988 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
Cleared
Traditional
MINI-FILTER, VIROBAC II
Apr 1988
Decision
70d
Days
Class 2
Risk
About This 510(k) Submission
K880681 is an FDA 510(k) clearance for the MINI-FILTER, VIROBAC II, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on April 29, 1988, 70 days after receiving the submission on February 19, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.
Device Classification
| Product Code | CAH — Filter, Bacterial, Breathing-circuit |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5260 |
Manufacturer
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