510(k) K905091

VARIOUS MALE QUICK CONNECTS. by Medical Fittings, Inc. — Product Code BYX

K905091 is an FDA 510(k) premarket notification submitted by Medical Fittings, Inc. for the device "VARIOUS MALE QUICK CONNECTS.". The FDA issued a decision of Substantially Equivalent on March 4, 1991. The device falls under product code BYX (Tubing, Pressure And Accessories), a Class I device regulated under 21 CFR 868.5860. Medical Fittings, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1991
Date Received
November 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Pressure And Accessories
Device Class
Class I
Regulation Number
868.5860
Review Panel
AN
Submission Type