The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Dart Daily Air Removal Test.
| Device ID | K844512 |
| 510k Number | K844512 |
| Device Name: | DART DAILY AIR REMOVAL TEST |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie, PA 16514 |
| Contact | James A Spallina |
| Correspondent | James A Spallina AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie, PA 16514 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-20 |
| Decision Date | 1985-03-21 |