The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Bi-o.k.(tm)-biological/chemical Indicator.
| Device ID | K891784 |
| 510k Number | K891784 |
| Device Name: | BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | PROPPER MFG. CO., INC. 3604 SKILLMAN AVE. Long Island City, NY 11101 |
| Contact | John D Dyckman |
| Correspondent | John D Dyckman PROPPER MFG. CO., INC. 3604 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 | 1989-03-24 |
| Decision Date | 1990-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30818087012349 | K891784 | 000 |
| 30818087012332 | K891784 | 000 |