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  |