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528
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522
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489
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485
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444
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510k Database
Manufacturers
US
Carapace, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Carapace, Inc. - FDA 510(k) Cleared Devices
22 submissions
·
10 cleared
·
Since 1979
22
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Carapace, Inc.
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 22, 1994
I.V. START KIT
K931729
·
FOZ
General Hospital
·
321d
Cleared
Feb 07, 1994
CARAPACE DEBRIDEMENT KITS
K931669
·
FRG
General Hospital
·
307d
Cleared
Dec 02, 1993
CARAPACE STERILE COTTON BALLS
K931626
·
FRL
General Hospital
·
244d
Cleared
Jul 03, 1979
SURGICAL FACE MASK
K790970
·
KKX
General Hospital
·
42d
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22
General & Plastic Surgery
9
General Hospital
4
Orthopedic
3
Obstetrics & Gynecology
2
Physical Medicine
2
Cardiovascular
1
Anesthesiology
1