The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Glass Loss Of Resistance Syringe.
| Device ID | K063018 |
| 510k Number | K063018 |
| Device Name: | GLASS LOSS OF RESISTANCE SYRINGE |
| Classification | Anesthesia Conduction Kit |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DR. Hauppauge, NY 11788 |
| Contact | Muhamad Ansari |
| Correspondent | Muhamad Ansari BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DR. Hauppauge, NY 11788 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-02 |
| Decision Date | 2007-01-22 |
| Summary: | summary |