The following data is part of a premarket notification filed by Gibeck, Inc. with the FDA for Humid-vent Filter Compact Angled (18402)/humid-vent Filter Compact Straight(19402).
| Device ID | K964382 |
| 510k Number | K964382 |
| Device Name: | HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236 |
| Contact | Chyrell Saunders |
| Correspondent | Chyrell Saunders GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-04 |
| Decision Date | 1997-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704644869 | K964382 | 000 |
| 44026704347962 | K964382 | 000 |
| 24026704348026 | K964382 | 000 |
| 44026704348648 | K964382 | 000 |
| 44026704348662 | K964382 | 000 |
| 24026704581485 | K964382 | 000 |
| 24026704717730 | K964382 | 000 |
| 24026704659245 | K964382 | 000 |
| 24026704659337 | K964382 | 000 |
| 24026704581478 | K964382 | 000 |
| 34026704734185 | K964382 | 000 |