The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Sterilmed Reprocessed Compression Sleeves.
| Device ID | K012597 |
| 510k Number | K012597 |
| Device Name: | STERILMED REPROCESSED COMPRESSION SLEEVES |
| Classification | Sleeve, Limb, Compressible |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Patrick Fleischhacker |
| Correspondent | Patrick Fleischhacker STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-10 |
| Decision Date | 2002-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888551004975 | K012597 | 000 |
| 20888551041796 | K012597 | 000 |
| 20888551041802 | K012597 | 000 |
| 20888551041819 | K012597 | 000 |
| 20888551041826 | K012597 | 000 |
| 20888551041833 | K012597 | 000 |
| 20888551041840 | K012597 | 000 |
| 20888551041857 | K012597 | 000 |
| 20888551042052 | K012597 | 000 |
| 20888551041789 | K012597 | 000 |
| 20888551041772 | K012597 | 000 |
| 20888551041765 | K012597 | 000 |
| 20888551041680 | K012597 | 000 |
| 20888551041697 | K012597 | 000 |
| 20888551041703 | K012597 | 000 |
| 20888551041710 | K012597 | 000 |
| 20888551041727 | K012597 | 000 |
| 20888551041734 | K012597 | 000 |
| 20888551041741 | K012597 | 000 |
| 20888551041758 | K012597 | 000 |
| 20888551042083 | K012597 | 000 |
| 20888551042090 | K012597 | 000 |
| 20888551042106 | K012597 | 000 |
| 20888551042557 | K012597 | 000 |
| 20888551042625 | K012597 | 000 |
| 20888551042632 | K012597 | 000 |
| 20888551042649 | K012597 | 000 |
| 20888551042656 | K012597 | 000 |
| 20888551042663 | K012597 | 000 |
| 20888551042670 | K012597 | 000 |
| 20888551042687 | K012597 | 000 |
| 20888551042311 | K012597 | 000 |
| 20888551042304 | K012597 | 000 |
| 20888551042298 | K012597 | 000 |
| 20888551042205 | K012597 | 000 |
| 20888551042212 | K012597 | 000 |
| 20888551042236 | K012597 | 000 |
| 20888551042243 | K012597 | 000 |
| 20888551042250 | K012597 | 000 |
| 20888551042267 | K012597 | 000 |
| 20888551042274 | K012597 | 000 |
| 20888551042281 | K012597 | 000 |
| 20888551042694 | K012597 | 000 |