The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Safety Drain.
Device ID | K881790 |
510k Number | K881790 |
Device Name: | SAFETY DRAIN |
Classification | Drain, Tee (water Trap) |
Applicant | BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
Contact | Ernest Chamberlain |
Correspondent | Ernest Chamberlain BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
Product Code | BYH |
CFR Regulation Number | 868.5995 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-26 |
Decision Date | 1988-06-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SAFETY DRAIN 73737410 1569479 Live/Registered |
BALLARD MEDICAL PRODUCTS 1988-06-30 |