The following data is part of a premarket notification filed by Repro-med Systems, Inc. with the FDA for Freedom 60 Syringe Infusion Pump System With Syringe Set & Tubing.
| Device ID | K933652 |
| 510k Number | K933652 |
| Device Name: | FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING |
| Classification | Pump, Infusion |
| Applicant | REPRO-MED SYSTEMS, INC. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff REPRO-MED SYSTEMS, INC. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-28 |
| Decision Date | 1994-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00659443002722 | K933652 | 000 |
| 10659443000121 | K933652 | 000 |
| 10659443000114 | K933652 | 000 |
| 10659443000107 | K933652 | 000 |
| 10659443000091 | K933652 | 000 |
| 10659443000084 | K933652 | 000 |
| 10659443000077 | K933652 | 000 |
| 10659443000060 | K933652 | 000 |
| 10659443000053 | K933652 | 000 |
| 10659443000046 | K933652 | 000 |
| 10659443000039 | K933652 | 000 |
| 10659443000138 | K933652 | 000 |
| 10659443000145 | K933652 | 000 |
| 00659443002715 | K933652 | 000 |
| 10659443000688 | K933652 | 000 |
| 10659443000220 | K933652 | 000 |
| 10659443000213 | K933652 | 000 |
| 10659443000206 | K933652 | 000 |
| 10659443000190 | K933652 | 000 |
| 10659443000183 | K933652 | 000 |
| 10659443000176 | K933652 | 000 |
| 10659443000169 | K933652 | 000 |
| 10659443000152 | K933652 | 000 |
| 10659443000022 | K933652 | 000 |