The following data is part of a premarket notification filed by Busse Hosipital Disposables with the FDA for Busse Plastic Lor Syringe.
| Device ID | K080804 |
| 510k Number | K080804 |
| Device Name: | BUSSE PLASTIC LOR SYRINGE |
| Classification | Anesthesia Conduction Kit |
| Applicant | BUSSE HOSIPITAL DISPOSABLES 75 ARKAY DR PO BOX 11067 Hauppauge, NY 11788 |
| Contact | Muhamad Ansari |
| Correspondent | Muhamad Ansari BUSSE HOSIPITAL DISPOSABLES 75 ARKAY DR PO BOX 11067 Hauppauge, NY 11788 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-03-21 |
| Decision Date | 2008-07-09 |
| Summary: | summary |