The following data is part of a premarket notification filed by Sterizign Precision Technologies, Llc with the FDA for Sterizign Signatur Device Protection System.
| Device ID | K171520 |
| 510k Number | K171520 |
| Device Name: | SteriZign Signatur Device Protection System |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | SteriZign Precision Technologies, LLC 74 Orion Street Brunswick, ME 04011 |
| Contact | Sonia Lutarewych |
| Correspondent | Robert O. Dean Compliance Systems International, LLC 1083 Delaware Ave. Buffalo, NY 14209 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-24 |
| Decision Date | 2018-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850037506095 | K171520 | 000 |
| G476STER10X10X4 | K171520 | 000 |
| G476STER10X15X2 | K171520 | 000 |
| G476STER10X15X3 | K171520 | 000 |
| G476STER10X20X2 | K171520 | 000 |
| G476STER10X20X3 | K171520 | 000 |
| G476STER10X20X4 | K171520 | 000 |
| G476STER10X10X2 | K171520 | 000 |
| M896IBIT00010 | K171520 | 000 |
| G476STER10X10X3 | K171520 | 000 |