The following data is part of a premarket notification filed by Bio-medical Sciences, Inc. with the FDA for Ethylene Oxide Sterili. Indicator.
| Device ID | K772358 |
| 510k Number | K772358 |
| Device Name: | ETHYLENE OXIDE STERILI. INDICATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | BIO-MEDICAL SCIENCES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-27 |
| Decision Date | 1978-01-30 |