The following data is part of a premarket notification filed by Cadema Medical Products, Inc. with the FDA for Entrapping Filter.
| Device ID | K896116 |
| 510k Number | K896116 |
| Device Name: | ENTRAPPING FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | CADEMA MEDICAL PRODUCTS, INC. P.O. BOX 250 Middletown, NY 10940 |
| Contact | Kathleen D Bordoni |
| Correspondent | Kathleen D Bordoni CADEMA MEDICAL PRODUCTS, INC. P.O. BOX 250 Middletown, NY 10940 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-20 |
| Decision Date | 1989-11-17 |