The following data is part of a premarket notification filed by Sterisil with the FDA for Sterisil Antimicrobial Tubing And Bottle.
Device ID | K031681 |
510k Number | K031681 |
Device Name: | STERISIL ANTIMICROBIAL TUBING AND BOTTLE |
Classification | Unit, Operative Dental |
Applicant | STERISIL 200 S. WILCOX Castle Rock, CO 80104 |
Contact | Brad Downs |
Correspondent | Brad Downs STERISIL 200 S. WILCOX Castle Rock, CO 80104 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2003-05-30 |
Decision Date | 2003-10-30 |