The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Chemspor.
| Device ID | K844479 |
| 510k Number | K844479 |
| Device Name: | CHEMSPOR |
| Classification | Indicator, Biological 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 | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-19 |
| Decision Date | 1985-11-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CHEMSPOR 73162640 1138526 Dead/Cancelled |
AMERICAN STERILIZER COMPANY 1978-03-17 |