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Site Microsurgical Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
30
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K925828MODIFIED SITE TXR SYSTEMSFebruary 16, 1994
K925921MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTEDecember 6, 1993
K931866SITE'S CD II PHACOEMULSIFICATION HANDPIECENovember 12, 1993
K921135IOLAB POWER I.V. POLEJune 3, 1992
K920582180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.May 8, 1992
K912902PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USEDecember 17, 1991
K912739SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USEAugust 28, 1991
K910980SITE 20 GAUGE REUSABLE FIBER OPTIC CABLEMay 22, 1991
K905620MODIFIED SITE PERISTALTIC FOOTSWITCHFebruary 27, 1991
K904183SITE PHACOEMULSIFICATION HANDPIECEDecember 5, 1990
K904151SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLEDecember 5, 1990
K904186SITE DIAPHRAGM CASSETTENovember 21, 1990
K896943SITE DISPOSABLE CUTTER AND ACCESSORIESMarch 8, 1990
K895663SITE 810E PHOTOCOAGULATOR AND ACCESSORIESDecember 4, 1989
K892852SITE PHACO PLUS INFUSION SLEEVEJune 8, 1989
K892911SITE PERISTALTIC CASSETTEMay 17, 1989
K883926.2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND.November 15, 1988
K883975DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.October 25, 1988
K883605MODIFIED REUSABLE SITE FIBER OPTIC CABLEOctober 25, 1988
K883099SITE MACROBORE PHACO NEEDLESeptember 15, 1988