The following data is part of a premarket notification filed by Case Medical, Inc. with the FDA for Steritite Process Indicator Accessories.
| Device ID | K982151 |
| 510k Number | K982151 |
| Device Name: | STERITITE PROCESS INDICATOR ACCESSORIES |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | CASE MEDICAL, INC. 65 RAILROAD AVE. Ridgefield, NJ 07657 -0402 |
| Contact | Marcia Frieze |
| Correspondent | Tania Lupu CASE MEDICAL, INC. 65 RAILROAD AVE. Ridgefield, NJ 07657 -0402 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-18 |
| Decision Date | 1999-02-09 |