510(k) K950600

VACUUM SURGE SUPRESSER by Surgin Surgical Instrumentation, Inc. — Product Code HQC

K950600 is an FDA 510(k) premarket notification submitted by Surgin Surgical Instrumentation, Inc. for the device "VACUUM SURGE SUPRESSER". The FDA issued a decision of Substantially Equivalent on May 10, 1995. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Surgin Surgical Instrumentation, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1995
Date Received
February 9, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type