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 | K133015 |
| 510k Number | K133015 |
| Device Name: | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | SUMMIT MEDICAL, INC. 815 NORTHWEST PKWY, STE 100 St. Paul, MN 55121 |
| Contact | Nicole Dove |
| Correspondent | Nicole Dove SUMMIT MEDICAL, INC. 815 NORTHWEST PKWY, STE 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 | 2013-09-25 |
| Decision Date | 2014-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B351EE10010 | K133015 | 000 |
| B351EE10000 | K133015 | 000 |