The following data is part of a premarket notification filed by Mdt Corp., Inc. with the FDA for Mdt Unispore And Spor-test Biologicalindicator.
| Device ID | K960777 |
| 510k Number | K960777 |
| Device Name: | MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | MDT CORP., INC. P.O BOX 23077 Rochester, NY 14692 |
| Contact | Charles O Hancock |
| Correspondent | Charles O Hancock MDT CORP., INC. 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 | 1996-02-26 |
| Decision Date | 1996-05-23 |
| Summary: | summary |