The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Sterile Mucus Specimen Trap, Models 406 & 407.
| Device ID | K875058 |
| 510k Number | K875058 |
| Device Name: | STERILE MUCUS SPECIMEN TRAP, MODELS 406 & 407 |
| 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 | 1987-12-09 |
| Decision Date | 1988-02-12 |