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 |