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Thantex Specialties, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K970547ISOLYSER SDS SHARPS CONTAINERJuly 18, 1997
K961083OREX SURGEON'S VESTAugust 23, 1996
K942200ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPSAugust 7, 1995
K943626ISOLYSER SHARPS MANAGEMENT SYSTEM SMSJune 16, 1995
K945755OREX(R) O.R EQUIPMENT DRAPESMay 25, 1995
K945223OREX ISOLATION GOWNApril 25, 1995
K944827OREX SURGEON'S GOWNFebruary 28, 1995
K944859OREX SURGICAL DRAPESFebruary 28, 1995
K943034OREX SHOE COVERSJanuary 2, 1995
K942228OREX O.R. TOWELDecember 20, 1994
K940764OREXDecember 19, 1994
K940767OREX (12X12 X-RAY DETECTABLE)December 19, 1994
K940765ISOLYSERDecember 19, 1994
K940716OREXDecember 19, 1994
K940766OREX (18X18 X-RAY DETECTABLE)December 19, 1994
K944953OREX MEDICAL BEDDINGDecember 2, 1994
K940757ISOLYSER (4X18) X-RAY DETECTABLEMay 2, 1994
K940762ISOLYSER (18X18 X-RAY DETECTABLE)May 2, 1994
K940754ISOLYER (4X4, 12 PLY)May 2, 1994
K940756ISOLYSER (X-RAY DETECTABLE)May 2, 1994