The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Infectious Disease Protection Kit, Disposable.
| Device ID | K874306 |
| 510k Number | K874306 |
| Device Name: | INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE |
| Classification | Chamber, Patient Isolation |
| 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 | LGM |
| CFR Regulation Number | 880.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-20 |
| Decision Date | 1988-03-22 |