The following data is part of a premarket notification filed by Summit Medical Inc. with the FDA for Instru-safe Instrument Protection System.
Device ID | K142630 |
510k Number | K142630 |
Device Name: | Instru-Safe Instrument Protection System |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | Summit Medical Inc. 815 Northwest Parkway, Suite 100 St. Paul, MN 55121 |
Contact | Nicole Dove |
Correspondent | Nicole Dove Summit Medical Inc. 815 Northwest Parkway, Suite 100 St. Paul, 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 | 2014-09-17 |
Decision Date | 2014-12-23 |
Summary: | summary |