The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Instru-safe Instrument Protection Systems.
| Device ID | K051157 |
| 510k Number | K051157 |
| Device Name: | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD SUITE 120 Eagan, MN 55121 |
| Contact | Tom A Lopac |
| Correspondent | Tom A Lopac MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD SUITE 120 Eagan, MN 55121 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-05 |
| Decision Date | 2005-09-01 |