The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Sterilmed Intermittent Compression System, Garment Models 400 Series.
| Device ID | K003857 |
| 510k Number | K003857 |
| Device Name: | STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES |
| Classification | Sleeve, Limb, Compressible |
| Applicant | STERILMED, INC. 3650 ANNAPOLIS LN. NORTH SUITE 170 Plymouth, MN 55447 |
| Contact | Patrick Fleischhacker |
| Correspondent | Patrick Fleischhacker STERILMED, INC. 3650 ANNAPOLIS LN. NORTH SUITE 170 Plymouth, MN 55447 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-13 |
| Decision Date | 2001-10-18 |