The following data is part of a premarket notification filed by Mdt Corp., Inc. with the FDA for Biosign Biological Indicator (eight Month Exp.).
| Device ID | K891366 |
| 510k Number | K891366 |
| Device Name: | BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.) |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | MDT CORP., INC. 1777 EAST HENRIETTA RD.(14623) P.O. BOX 23077 Rochester, NY 14692 |
| Contact | Patrick Mccormick |
| Correspondent | Patrick Mccormick MDT CORP., INC. 1777 EAST HENRIETTA RD.(14623) P.O. BOX 23077 Rochester, NY 14692 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-03 |
| Decision Date | 1989-03-29 |