The following data is part of a premarket notification filed by Indilab, Inc. with the FDA for Indistrip Green.
| Device ID | K110369 |
| 510k Number | K110369 |
| Device Name: | INDISTRIP GREEN |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | INDILAB, INC. 10367 FRANKLIN AVE. Franklin Park, IL 60131 |
| Contact | Mark Espenscheid |
| Correspondent | Mark Espenscheid INDILAB, INC. 10367 FRANKLIN AVE. Franklin Park, IL 60131 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-08 |
| Decision Date | 2011-05-06 |
| Summary: | summary |