The following data is part of a premarket notification filed by Dana Products, Inc. with the FDA for Dana Reusable Testpack For Steam Sterilization For 10 Minute Extended Cycles.
| Device ID | K103321 |
| 510k Number | K103321 |
| Device Name: | DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | DANA PRODUCTS, INC. 7 COREY DR. South Barrington, IL 60010 |
| Contact | Harry Bala |
| Correspondent | Harry Bala DANA PRODUCTS, INC. 7 COREY DR. South Barrington, IL 60010 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-12 |
| Decision Date | 2011-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50724995152272 | K103321 | 000 |
| 50724995153217 | K103321 | 000 |