The following data is part of a premarket notification filed by Steritec Products Mfg. Co., Inc. with the FDA for Steritec Lead Free Sterilization Process Indicator Tape.
| Device ID | K122555 |
| 510k Number | K122555 |
| Device Name: | STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERITEC PRODUCTS MFG. CO., INC. 74 INVERNESS DRIVE EAST Englewood, CO 80112 |
| Contact | Jonathan Rutigliano |
| Correspondent | Jonathan Rutigliano STERITEC PRODUCTS MFG. CO., INC. 74 INVERNESS DRIVE EAST Englewood, CO 80112 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-22 |
| Decision Date | 2012-12-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814434020452 | K122555 | 000 |
| 50885380120174 | K122555 | 000 |
| 40884389943183 | K122555 | 000 |
| 40884389943176 | K122555 | 000 |
| 10814434020179 | K122555 | 000 |
| 10814434020186 | K122555 | 000 |
| 10814434020421 | K122555 | 000 |
| 10814434020438 | K122555 | 000 |
| 10814434020445 | K122555 | 000 |
| 50885380120167 | K122555 | 000 |