510(k) K803136

CONPHAR CRUTCH TIPS by Conphar, Inc. — Product Code INP

K803136 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR CRUTCH TIPS". The FDA issued a decision of Substantially Equivalent on January 8, 1981. The device falls under product code INP (Tips And Pads, Cane, Crutch And Walker), a Class I device regulated under 21 CFR 890.3790. Conphar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1981
Date Received
December 12, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tips And Pads, Cane, Crutch And Walker
Device Class
Class I
Regulation Number
890.3790
Review Panel
PM
Submission Type