The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for I.v. Start Kit, Sterile, Disposables.
| Device ID | K863712 |
| 510k Number | K863712 |
| Device Name: | I.V. START KIT, STERILE, DISPOSABLES |
| Classification | I.v. Start Kit |
| 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 | LRS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-23 |
| Decision Date | 1986-10-22 |