510(k) K881790

SAFETY DRAIN by Ballard Medical Products — Product Code BYH

K881790 is an FDA 510(k) premarket notification submitted by Ballard Medical Products for the device "SAFETY DRAIN". The FDA issued a decision of Substantially Equivalent on June 21, 1988. The device falls under product code BYH (Drain, Tee (Water Trap)), a Class I device regulated under 21 CFR 868.5995. Ballard Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1988
Date Received
April 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drain, Tee (Water Trap)
Device Class
Class I
Regulation Number
868.5995
Review Panel
AN
Submission Type