The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Busse Bac/shield.
| Device ID | K902297 |
| 510k Number | K902297 |
| Device Name: | BUSSE BAC/SHIELD |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 11067 Hauppauge, NY 11788 |
| Contact | Partha Basumallik |
| Correspondent | Partha Basumallik BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 11067 Hauppauge, NY 11788 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-23 |
| Decision Date | 1990-08-17 |