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 |