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510k Database
Manufacturers
US
Pollak (Intl.), Ltd.
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Medical Device Manufacturer
·
US , Mchenry , IL
Pollak (Intl.), Ltd. - FDA 510(k) Cleared Devices
31 submissions
·
31 cleared
·
Since 1980
Recent clearances:
UMBICUT
,
PEDICAT*
,
VECAFIX*
31
Total
31
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pollak (Intl.), Ltd.
Gastroenterology & Urology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 31, 1980
FLOWCLAMP CAT.#1011 & 1012
K802009
·
FKK
Gastroenterology & Urology
·
72d
Cleared
Sep 26, 1980
PEDIWET=GUAZE IMPREGNATED WITH PETROL
K802007
·
FRQ
Gastroenterology & Urology
·
37d
Cleared
Sep 09, 1980
TRIBAG, URINE BAG SYSTEM #1109,& 1301-12
K802012
·
KNX
Gastroenterology & Urology
·
20d
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31
General & Plastic Surgery
15
General Hospital
10
Gastroenterology & Urology
3
Microbiology
1
Obstetrics & Gynecology
1
Physical Medicine
1