The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Bi-o.k. Self-contained Biological Indicator.
| Device ID | K991618 |
| 510k Number | K991618 |
| Device Name: | BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | PROPPER MFG. CO., INC. 36-04 SKILLMAN AVE. Long Island City, NY 11101 |
| Contact | John D Dyckman |
| Correspondent | John D Dyckman PROPPER MFG. CO., INC. 36-04 SKILLMAN AVE. Long Island City, NY 11101 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-11 |
| Decision Date | 2001-01-24 |
| Summary: | summary |