The following data is part of a premarket notification filed by Sultan Chemists, Inc. with the FDA for Sultan Sporox Test Vial, Model 75195.
| Device ID | K020612 |
| 510k Number | K020612 |
| Device Name: | SULTAN SPOROX TEST VIAL, MODEL 75195 |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | SULTAN CHEMISTS, INC. 85 WEST FOREST AVE. Englewood, NJ 07631 |
| Contact | Clark Smith |
| Correspondent | Clark Smith SULTAN CHEMISTS, INC. 85 WEST FOREST AVE. Englewood, NJ 07631 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-25 |
| Decision Date | 2002-05-07 |