The following data is part of a premarket notification filed by Advanced Medical Products, Inc. with the FDA for Urodynamics Tubing Kits #5161, #5150, #7170.
| Device ID | K923995 |
| 510k Number | K923995 |
| Device Name: | URODYNAMICS TUBING KITS #5161, #5150, #7170 |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | ADVANCED MEDICAL PRODUCTS, INC. P.O. BOX 10040 Merrillville, IN 46411 |
| Contact | Joel J Rosen |
| Correspondent | Joel J Rosen ADVANCED MEDICAL PRODUCTS, INC. P.O. BOX 10040 Merrillville, IN 46411 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-10 |
| Decision Date | 1993-04-08 |