The following data is part of a premarket notification filed by King Systems Corp. with the FDA for Mini-filter, Virobac Ii.
| Device ID | K880681 |
| 510k Number | K880681 |
| Device Name: | MINI-FILTER, VIROBAC II |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
| Contact | Linda L Nordlund |
| Correspondent | Linda L Nordlund KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-19 |
| Decision Date | 1988-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00612649102337 | K880681 | 000 |
| 00612649102313 | K880681 | 000 |
| 00612649102290 | K880681 | 000 |
| 00612649182353 | K880681 | 000 |
| 00612649215419 | K880681 | 000 |