The following data is part of a premarket notification filed by Princeton Regulatory Assoc. with the FDA for Urosurge Acutrainer.
| Device ID | K962770 |
| 510k Number | K962770 |
| Device Name: | UROSURGE ACUTRAINER |
| Classification | Alarm, Conditioned Response Enuresis |
| Applicant | PRINCETON REGULATORY ASSOC. 116 VILLAGE BLVD., SUITE 200 Princeton, NJ 08540 -5799 |
| Contact | Thomas Becze |
| Correspondent | Thomas Becze PRINCETON REGULATORY ASSOC. 116 VILLAGE BLVD., SUITE 200 Princeton, NJ 08540 -5799 |
| Product Code | KPN |
| CFR Regulation Number | 876.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-16 |
| Decision Date | 1996-08-01 |