510(k) K993361

TUBING EXTENSION SET by Hurricane Medical — Product Code MSR

K993361 is an FDA 510(k) premarket notification submitted by Hurricane Medical for the device "TUBING EXTENSION SET". The FDA issued a decision of Substantially Equivalent on January 4, 2000. The device falls under product code MSR (Tubing, Replacement, Phacofragmentation Unit), a Class II device regulated under 21 CFR 886.4150. Hurricane Medical has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2000
Date Received
October 6, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Replacement, Phacofragmentation Unit
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type