The following data is part of a premarket notification filed by Meds Systems, Inc. with the FDA for Thera-flow Gradient Sequential Pump.
| Device ID | K943392 |
| 510k Number | K943392 |
| Device Name: | THERA-FLOW GRADIENT SEQUENTIAL PUMP |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MEDS SYSTEMS, INC. 1110 BUSINESS PKWY. SOUTH Westminster, MD 21157 |
| Contact | Charles Grempler |
| Correspondent | Charles Grempler MEDS SYSTEMS, INC. 1110 BUSINESS PKWY. SOUTH Westminster, MD 21157 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-14 |
| Decision Date | 1994-12-30 |