510(k) K885088

THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM by Thayer Medical Corp. — Product Code BYH

K885088 is an FDA 510(k) premarket notification submitted by Thayer Medical Corp. for the device "THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 12, 1989. The device falls under product code BYH (Drain, Tee (Water Trap)), a Class I device regulated under 21 CFR 868.5995. Thayer Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1989
Date Received
December 12, 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