The following data is part of a premarket notification filed by Jewel Precision Sheet Metal & Machine, Inc. with the FDA for Jewel Precision Reusable Rigid Sterilization Container System.
| Device ID | K162600 |
| 510k Number | K162600 |
| Device Name: | Jewel Precision Reusable Rigid Sterilization Container System |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | JEWEL PRECISION SHEET METAL & MACHINE, INC. 200 COMMERCE ROAD Cedar Grove, NJ 07009 |
| Contact | Gary Schneberger |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-09-19 |
| Decision Date | 2016-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850043393122 | K162600 | 000 |
| 00850043393115 | K162600 | 000 |
| 00850043393108 | K162600 | 000 |
| 00850043393092 | K162600 | 000 |
| 00850043393023 | K162600 | 000 |
| 00850043393016 | K162600 | 000 |
| 00840314269645 | K162600 | 000 |