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 |