The following data is part of a premarket notification filed by 3m Company with the FDA for Attest Rapid Readout Biological Indicator For Eo, Model 1294; Attest Rapid Readout Biological Indicator For Eo Test Pack.
| Device ID | K031012 |
| 510k Number | K031012 |
| Device Name: | ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55133 -3275 |
| Contact | Cynthia Lamarucciola |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-03-31 |
| Decision Date | 2003-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387470406 | K031012 | 000 |
| 50707387470390 | K031012 | 000 |
| 50707387470383 | K031012 | 000 |