The following data is part of a premarket notification filed by Indilab, Inc. with the FDA for Indistrip (sterilization Process Indicator).
| Device ID | K875193 |
| 510k Number | K875193 |
| Device Name: | INDISTRIP (STERILIZATION PROCESS INDICATOR) |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | INDILAB, INC. 8010 SALISBURY Lyons, IL 60534 |
| Contact | Robert Gavrick |
| Correspondent | Robert Gavrick INDILAB, INC. 8010 SALISBURY Lyons, IL 60534 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-17 |
| Decision Date | 1988-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000763615 | K875193 | 000 |
| 10889950002473 | K875193 | 000 |