The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Scrub Mate Dry Sterile Scrub Brush.
| Device ID | K844411 |
| 510k Number | K844411 |
| Device Name: | SCRUB MATE DRY STERILE SCRUB BRUSH |
| Classification | Brush, Scrub, Operating-room |
| 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 | GEC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-14 |
| Decision Date | 1984-12-17 |