The following data is part of a premarket notification filed by Robert Busse & Co., Inc. with the FDA for Loss Of Resistance Syringe.
| Device ID | K061737 |
| 510k Number | K061737 |
| Device Name: | LOSS OF RESISTANCE SYRINGE |
| Classification | Anesthesia Conduction Kit |
| Applicant | ROBERT BUSSE & CO., INC. P.O. BOX 11067 Hauppauge, NY 11788 |
| Contact | Muhamad Ansari |
| Correspondent | Muhamad Ansari ROBERT BUSSE & CO., INC. P.O. BOX 11067 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 | 2006-06-20 |
| Decision Date | 2006-12-18 |
| Summary: | summary |