The following data is part of a premarket notification filed by Steritec Products Mfg. Co., Inc. with the FDA for Steritec Green Card Pack Bowie-dick Test.
| Device ID | K132372 |
| 510k Number | K132372 |
| Device Name: | STERITEC GREEN CARD PACK BOWIE-DICK TEST |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-30 |
| Decision Date | 2013-11-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814434020268 | K132372 | 000 |