The following data is part of a premarket notification filed by Westmed Intl. with the FDA for Westmed Pediatric Bacterial/viral Filter.
| Device ID | K953687 |
| 510k Number | K953687 |
| Device Name: | WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | WESTMED INTL. 3351 EAST HEMISPHERE LOOP Tucson, AZ 85706 |
| Contact | Lynn D Hayse |
| Correspondent | Lynn D Hayse WESTMED INTL. 3351 EAST HEMISPHERE LOOP Tucson, AZ 85706 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-07 |
| Decision Date | 1995-09-18 |