The following data is part of a premarket notification filed by Orthoconcept, Inc. with the FDA for Modified Uropump* Fluid Management System.
| Device ID | K895643 |
| 510k Number | K895643 |
| Device Name: | MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM |
| Classification | Resectoscope, Working Element |
| Applicant | ORTHOCONCEPT, INC. 8 COLD BRANCH CT Columbia, SC 29223 |
| Contact | Jack Defranco |
| Correspondent | Jack Defranco ORTHOCONCEPT, INC. 8 COLD BRANCH CT Columbia, SC 29223 |
| Product Code | FDC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-28 |
| Decision Date | 1989-10-17 |