510(k) K895479

THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM by Thayer Medical Corp. — Product Code BYH

K895479 is an FDA 510(k) premarket notification submitted by Thayer Medical Corp. for the device "THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on March 9, 1990. 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
March 9, 1990
Date Received
September 11, 1989
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