The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Saline Solutine, Sterile.
| Device ID | K950560 |
| 510k Number | K950560 |
| Device Name: | SALINE SOLUTINE, STERILE |
| Classification | Solution, Formalin Ammonium Bromide |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 11067 Hauppauge, NY 11788 |
| Contact | Eileen Rama |
| Correspondent | Eileen Rama BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 11067 Hauppauge, NY 11788 |
| Product Code | IGE |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-08 |
| Decision Date | 1995-05-30 |