Atlas FDA

CERETENE SOLUBLE IMPLANT MATERIAL

FDA 510(k) clearance K103047 · decided 2011-01-05

Clearance details

K-number
K103047
Device name
CERETENE SOLUBLE IMPLANT MATERIAL
Applicant
Ceremed , Inc.
Decision
Substantially Equivalent
Date received
2010-10-15
Decision date
2011-01-05
Days to decision
82 days
Clearance type
Traditional
Product code
KHJ
Device class
2
Regulation number
874.3620
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Los Angeles, CA, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI (K132198)Ceremed , Inc.2013-09-12
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ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN (K122561)Ceremed , Inc.2012-11-27
ADAPTAIN SOLUBLE IMPLANT MATERIAL (K120220)Ceremed , Inc.2012-06-06
GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP (K080022)Vascular Solutions, Inc.2008-12-09
AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV (K082245)Ceremed , Inc.2008-09-18
AOC SOLUBLE IMPLANT MATERIAL (K081531)Ceremed , Inc.2008-07-18
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE (K070093)Ceremed , Inc.2007-01-24
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE (K062280)Ceremed , Inc.2006-12-11

Recalls involving this device

No recalls on record reference this clearance.