Biopor, AOC Porous Polyethylene, Cerepor
K-Number: K160988 · 2016-07-14
ApplicantCeremed , Inc.
Decision Date2016-07-14
Product CodeKKY
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Biopor, AOC Porous Polyethylene, Cerepor is a medical device manufactured by Ceremed , Inc.. It received FDA 510(k) clearance on 2016-07-14 under approval number K160988. The device is classified under product code KKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Biopor, AOC Porous Polyethylene, Cerepor?
Biopor, AOC Porous Polyethylene, Cerepor is a medical device that received FDA 510(k) clearance on 2016-07-14. It is manufactured by Ceremed , Inc.. The 510(k) number is K160988.
When was Biopor, AOC Porous Polyethylene, Cerepor approved by the FDA?
Biopor, AOC Porous Polyethylene, Cerepor received FDA 510(k) clearance on 2016-07-14, under approval number K160988.
What company makes Biopor, AOC Porous Polyethylene, Cerepor?
Biopor, AOC Porous Polyethylene, Cerepor is manufactured by Ceremed , Inc..
What is the FDA product code for Biopor, AOC Porous Polyethylene, Cerepor?
The FDA product code for Biopor, AOC Porous Polyethylene, Cerepor is KKY.
Other Devices by Ceremed , Inc.
Related Devices (Code: KKY)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.