The following data is part of a premarket notification filed by Reprocessing Products Corp. with the FDA for Port Caps (protective Closures Foe Reprocessed Hemodialyzers.
| Device ID | K950602 |
| 510k Number | K950602 |
| Device Name: | PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | REPROCESSING PRODUCTS CORP. 2730 EAST BROADWAY BLVD. SUITE 135 P.O. BOX 40970 Tucson, AZ 85716 |
| Contact | Michael Honstein |
| Correspondent | Michael Honstein REPROCESSING PRODUCTS CORP. 2730 EAST BROADWAY BLVD. SUITE 135 P.O. BOX 40970 Tucson, AZ 85716 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-09 |
| Decision Date | 1995-11-30 |